Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Anterolateral Inserter, Large Footprint, 10-12mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-1319
In Commercial Distribution

  • 00191375040118 ()

  • Length: 15 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable
Anterolateral Inserter, XL Footprint, 10-12mm
MEDTRONIC SOFAMOR DANEK, INC.
2300-1318
In Commercial Distribution

  • 00191375040101 ()

  • Length: 15 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable
Anterolateral Inserter, X-Large Footprint
MEDTRONIC SOFAMOR DANEK, INC.
2300-1303
In Commercial Distribution

  • 00191375039983 ()

  • Length: 15 Inch


  • Orthopaedic inorganic implant inserter/extractor, reusable
Angled Driver, Handle
MEDTRONIC SOFAMOR DANEK, INC.
2300-1323
In Commercial Distribution

  • 00191375050469 ()

  • Width: 6 Inch


  • Orthopaedic implant driver
24 Deg Lordotic, Rasp Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
842-200-010
In Commercial Distribution

  • 00191375050988 ()

  • TAS 24 Deg Lordotic, Rasp Caddy, Base
  • Width: 7 Inch
  • Length: 5 Inch


  • Instrument tray, reusable
24 Deg Lordotic, Rasp Caddy
MEDTRONIC SOFAMOR DANEK, INC.
842-200-008
In Commercial Distribution

  • 00191375050971 ()

  • Height: 1.5 Inch
  • Width: 7 Inch
  • TAS 24 Deg Lordotic, Rasp Caddy, Lid
  • Length: 5 Inch


  • Instrument tray, reusable
20 Deg Lordotic, Rasp Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
842-200-006
In Commercial Distribution

  • 00191375050964 ()

  • Width: 7 Inch
  • TAS 20 Deg Lordotic, Rasp Caddy, Lid
  • Length: 6 Inch


  • Instrument tray, reusable
20 Deg Lordotic, Rasp Caddy
MEDTRONIC SOFAMOR DANEK, INC.
842-200-005
In Commercial Distribution

  • 00191375050957 ()

  • Width: 7 Inch
  • TAS 20 Deg Lordotic, Rasp Caddy, Base
  • Length: 6 Inch
  • Height: 1.5 Inch


  • Instrument tray, reusable
16 Deg Lordotic, Rasp Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
842-200-004
In Commercial Distribution

  • 00191375050940 ()

  • Length: 6 Inch
  • Width: 7 Inch
  • TAS 16 Deg Lordotic, Rasp Caddy, Lid


  • Instrument tray, reusable
16 Deg Lordotic, Rasp Caddy
MEDTRONIC SOFAMOR DANEK, INC.
842-200-003
In Commercial Distribution

  • 00191375050933 ()

  • Width: 7 Inch
  • Length: 6 Inch
  • Height: 1.5 Inch
  • TAS 16 Deg Lordotic, Rasp Caddy, Base


  • Instrument tray, reusable
12 Deg Lordotic, X-Large Implant, Caddy
MEDTRONIC SOFAMOR DANEK, INC.
22-05680-00
In Commercial Distribution

  • 00191375050803 ()

  • TAS Implant Caddy
  • Width: 5 Inch
  • Height: 2 Inch
  • 12 Deg Lordotic, X-Large
  • Length: 8 Inch


  • Instrument tray, reusable
12 Deg Lordotic, Large Implant, Caddy
MEDTRONIC SOFAMOR DANEK, INC.
22-05678-00
In Commercial Distribution

  • 00191375050780 ()

  • TAS Implant Caddy
  • Height: 2 Inch
  • 12 Deg Lordotic, Large
  • Width: 5 Inch
  • Length: 8 Inch


  • Instrument tray, reusable
12 Deg Lordotic, Standard Implant, Caddy
MEDTRONIC SOFAMOR DANEK, INC.
22-05676-00
In Commercial Distribution

  • 00191375050766 ()

  • Length: 8 Inch
  • Height: 2 Inch
  • TAS Implant Caddy
  • Width: 5 Inch
  • 12 Deg Lordotic, Standard


  • Instrument tray, reusable
12 Deg Lordotic, Rasp Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05478-00
In Commercial Distribution

  • 00191375050759 ()

  • Length: 8 Inch
  • TAS 12 Deg Lordotic, Rasp Caddy, Lid
  • Width: 7 Inch


  • Instrument tray, reusable
7 Deg Lordotic, Rasp Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05476-00
In Commercial Distribution

  • 00191375050735 ()

  • TAS 7 Deg Lordotic, Rasp Caddy, Lid
  • Width: 7 Inch
  • Length: 8 Inch


  • Instrument tray, reusable
12 Deg Lordotic, Trial Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05466-00
In Commercial Distribution

  • 00191375050711 ()

  • Length: 9 Inch
  • Width: 7 Inch
  • TAS 12 Deg Lordotic. Rasp Caddy, Lid


  • Instrument tray, reusable
7 Deg Lordotic, Trial Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05464-00
In Commercial Distribution

  • 00191375050698 ()

  • Width: 7 Inch
  • Length: 9 Inch
  • TAS 7 Deg Lordotic. Rasp Caddy, Lid


  • Instrument tray, reusable
7 Deg Lordotic, X-Large Implant, Caddy
MEDTRONIC SOFAMOR DANEK, INC.
22-04947-00
In Commercial Distribution

  • 00191375050575 ()

  • Width: 5 Inch
  • Length: 8 Inch
  • 7 Deg Lordotic, X-Large
  • Height: 2 Inch
  • TAS Implant Caddy


  • Instrument tray, reusable
7 Deg Lordotic, Large Implant, Caddy
MEDTRONIC SOFAMOR DANEK, INC.
22-04946-00
In Commercial Distribution

  • 00191375050568 ()

  • 7 Deg Lordotic, Large
  • Height: 2 Inch
  • Length: 8 Inch
  • Width: 5 Inch
  • TAS Implant Caddy


  • Instrument tray, reusable
7 Deg Lordotic, Standard Implant, Caddy
MEDTRONIC SOFAMOR DANEK, INC.
22-04945-00
In Commercial Distribution

  • 00191375050551 ()

  • Height: 2 Inch
  • 7 Deg Lordotic, Standard
  • Length: 8 Inch
  • Width: 5 Inch
  • TAS Implant Caddy


  • Instrument tray, reusable
Rigid Container System, Tray
MEDTRONIC SOFAMOR DANEK, INC.
11-01452-00
In Commercial Distribution

  • 00191375032120 ()

  • Height: 3 Inch
  • Width: 10 Inch
  • Length: 21 Inch
  • Tray 4
  • TAS Instrument, Rigid Container System, Tray


  • Instrument tray, reusable
Rigid Container System, Tray
MEDTRONIC SOFAMOR DANEK, INC.
11-01447-00
In Commercial Distribution

  • 00191375032113 ()

  • Height: 3 Inch
  • TAS Instrument, Rigid Container System, Tray
  • Tray 3
  • Length: 21 Inch
  • Width: 10 Inch


  • Instrument tray, reusable
Rigid Container System, Tray
MEDTRONIC SOFAMOR DANEK, INC.
11-01443-00
In Commercial Distribution

  • 00191375032083 ()

  • Tray 2
  • Width: 10 Inch
  • TAS Instrument, Rigid Container System, Tray
  • Length: 21 Inch
  • Height: 3 Inch


  • Instrument tray, reusable
Rigid Container System, Tray
MEDTRONIC SOFAMOR DANEK, INC.
11-01442-00
In Commercial Distribution

  • 00191375032076 ()

  • Height: 3 Inch
  • Length: 21 Inch
  • TAS Instrument, Rigid Container System, Tray
  • Tray 1
  • Width: 10 Inch


  • Instrument tray, reusable
7 Deg Lordotic, X-Large Implant, Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05705-00
In Commercial Distribution

  • 00191375050834 ()

  • Length: 8 Inch
  • Width: 5 Inch
  • TAS Implant Caddy, Lid
  • 7 Deg Lordotic, X-Large


  • Instrument tray, reusable
7 Deg Lordotic, Large Implant, Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05704-00
In Commercial Distribution

  • 00191375050827 ()

  • Width: 5 Inch
  • Length: 8 Inch
  • TAS Implant Caddy, Lid
  • 7 Deg Lordotic, Large


  • Instrument tray, reusable
12 Deg Lordotic, X-Large Implant, Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05681-00
In Commercial Distribution

  • 00191375050810 ()

  • Length: 8 Inch
  • TAS Implant Caddy, Lid
  • Width: 5 Inch
  • 12 Deg Lordotic, X-Large


  • Instrument tray, reusable
12 Deg Lordotic, Large Implant, Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05679-00
In Commercial Distribution

  • 00191375050797 ()

  • Length: 8 Inch
  • TAS Implant Caddy, Lid
  • 12 Deg Lordotic, Large
  • Width: 5 Inch


  • Instrument tray, reusable
12 Deg Lordotic, Standard Implant, Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-05677-00
In Commercial Distribution

  • 00191375050773 ()

  • Width: 5 Inch
  • Length: 8 Inch
  • TAS Implant Caddy, Lid
  • 12 Deg Lordotic, Standard


  • Instrument tray, reusable
7 Deg Lordotic, Standard Implant, Caddy, Lid
MEDTRONIC SOFAMOR DANEK, INC.
22-04948-00
In Commercial Distribution

  • 00191375050582 ()

  • TAS Implant Caddy, Lid
  • Width: 5 Inch
  • 7 Deg Lordotic, Standard
  • Length: 8 Inch


  • Instrument tray, reusable
.25 SQ. Quick Connect Ratcheting T-Handle
TITAN SPINE, LLC
2300-1315
Not in Commercial Distribution

  • M682230013150 ()
2300-1315

  • Surgical instrument handle, non-torque-limiting
Quick Inserter
TITAN SPINE, LLC
2300-1312
Not in Commercial Distribution

  • M682230013120 ()
2300-1312

  • Orthopaedic inorganic implant inserter/extractor, reusable
TSA Elite Harness
1073849 Ontario Limited
T016-BSO
In Commercial Distribution

  • 00817956023263 ()

  • Height: 13 Inch
  • Width: 8 Inch
  • Depth: 4 Inch


  • Stand-up mobile patient lifting system sling/harness
Perforated Inner Tray, Lower
MEDTRONIC SOFAMOR DANEK, INC.
11-01446-00
In Commercial Distribution

  • 00191375032106 ()

  • Height: 2 Inch
  • Width: 10 Inch
  • Bottom Tray
  • Length: 21 Inch
  • TAS Implant, Rigid Tray System, Inner Tray


  • Instrument tray, reusable
Perforated Inner Tray, Upper
MEDTRONIC SOFAMOR DANEK, INC.
11-01445-00
In Commercial Distribution

  • 00191375032090 ()

  • Height: 2 Inch
  • Width: 10 Inch
  • TAS Implant, Rigid Tray System, Inner Tray
  • Top Tray
  • Length: 21 Inch


  • Instrument tray, reusable
Trial, Anterolateral, 7 Deg Lordotic, X-Large, 17mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9317
In Commercial Distribution

  • 00191375028666 ()

  • Depth: 27 Millimeter
  • Height: 17 Millimeter
  • Angle: 7 degree
  • Lordotic Angle 7 Deg
  • Width: 40 Millimeter
  • width(MLxAP), 40 x 27, mm


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, X-Large, 16mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9316
In Commercial Distribution

  • 00191375028659 ()

  • Lordotic Angle 7 Deg
  • Width: 40 Millimeter
  • Height: 16 Millimeter
  • Angle: 7 degree
  • width(MLxAP), 40 x 27, mm
  • Depth: 27 Millimeter


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, X-Large, 15mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9315
In Commercial Distribution

  • 00191375028642 ()

  • Width: 40 Millimeter
  • Height: 15 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Angle: 7 degree
  • Depth: 27 Millimeter
  • Lordotic Angle 7 Deg


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, X-Large, 14mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9314
In Commercial Distribution

  • 00191375028635 ()

  • Height: 14 Millimeter
  • Width: 40 Millimeter
  • Depth: 27 Millimeter
  • Lordotic Angle 7 Deg
  • width(MLxAP), 40 x 27, mm
  • Angle: 7 degree


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, X-Large, 12mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9312
In Commercial Distribution

  • 00191375028611 ()

  • Width: 40 Millimeter
  • Height: 12 Millimeter
  • Depth: 27 Millimeter
  • Lordotic Angle 7 Deg
  • width(MLxAP), 40 x 27, mm
  • Angle: 7 degree


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, X-Large, 10mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9310
In Commercial Distribution

  • 00191375028598 ()

  • width(MLxAP), 40 x 27, mm
  • Depth: 27 Millimeter
  • Lordotic Angle 7 Deg
  • Angle: 7 degree
  • Width: 40 Millimeter
  • Height: 10 Millimeter


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, X-Large, 8mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9308
In Commercial Distribution

  • 00191375028574 ()

  • Height: 8 Millimeter
  • Depth: 27 Millimeter
  • width(MLxAP), 40 x 27, mm
  • Angle: 7 degree
  • Lordotic Angle 7 Deg
  • Width: 40 Millimeter


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Large, 16mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9216
In Commercial Distribution

  • 00191375028550 ()

  • Lordotic Angle 7 Deg
  • Angle: 7 degree
  • Depth: 24 Millimeter
  • Width: 36 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Height: 16 Millimeter


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Large, 14mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9214
In Commercial Distribution

  • 00191375028536 ()

  • Angle: 7 degree
  • Lordotic Angle 7 Deg
  • Depth: 24 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Height: 14 Millimeter
  • Width: 36 Millimeter


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Large, 12mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9212
In Commercial Distribution

  • 00191375028512 ()

  • Depth: 24 Millimeter
  • Height: 12 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Lordotic Angle 7 Deg
  • Width: 36 Millimeter
  • Angle: 7 degree


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Large, 11mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9211
In Commercial Distribution

  • 00191375028505 ()

  • Depth: 24 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Angle: 7 degree
  • Width: 36 Millimeter
  • Lordotic Angle 7 Deg
  • Height: 11 Millimeter


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Large, 10mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9210
In Commercial Distribution

  • 00191375028499 ()

  • Depth: 24 Millimeter
  • Lordotic Angle 7 Deg
  • Width: 36 Millimeter
  • Height: 10 Millimeter
  • Angle: 7 degree
  • width(MLxAP), 36 x 24, mm


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Large, 9mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9209
In Commercial Distribution

  • 00191375028482 ()

  • Height: 9 Millimeter
  • width(MLxAP), 36 x 24, mm
  • Depth: 24 Millimeter
  • Width: 36 Millimeter
  • Angle: 7 degree
  • Lordotic Angle 7 Deg


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Standard, 8mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9108
In Commercial Distribution

  • 00191375028475 ()

  • Depth: 21 Millimeter
  • Lordotic Angle 7 Deg
  • Width: 32 Millimeter
  • Angle: 7 degree
  • Height: 8 Millimeter
  • width(MLxAP), 32 x 21, mm


  • Spinal implant trial
Trial, Anterolateral, 7 Deg Lordotic, Standard, 17mm
MEDTRONIC SOFAMOR DANEK, INC.
2307-9117
In Commercial Distribution

  • 00191375028468 ()

  • Height: 17 Millimeter
  • Depth: 21 Millimeter
  • Angle: 7 degree
  • Width: 32 Millimeter
  • width(MLxAP), 32 x 21, mm
  • Lordotic Angle 7 Deg


  • Spinal implant trial
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