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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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Inion OTPS™ Biodegradable Screw - M224FRF12079

2.5 x 8 mm screw (5 x)
Inion Oy
1
In Commercial Distribution

  • M224FRF12079 ()
FRF-1207

  • Bioabsorbable orthopaedic bone screw

Inion OTPS™ Biodegradable Screw - M224FRF12069

2.5 x 12 mm screw (5 x)
Inion Oy
1
In Commercial Distribution

  • M224FRF12069 ()
FRF-1206

  • Bioabsorbable orthopaedic bone screw

Inion OTPS BioRestore™ - M224BRS16009

Block 30 x 20 x 8 mm
Inion Oy
1
In Commercial Distribution

  • M224BRS16009 ()
BRS-1600

  • Synthetic bone graft

NA - ESOT009021

CB-2 Clamp-Sterilizationcase, 290 x 175 x 33mm
S & T AG
CB-2
In Commercial Distribution

  • ESOT009021 ()
00902

  • Surgical instrument/implant rack

STOMA® - ESAM6679001

Accessory box 80 x 40 x 20mm
Storz am Mark GmbH
6679.00
In Commercial Distribution

  • ESAM6679000 ()
  • ESAM6679001 ()
6679.00

  • Instrument tray, reusable

TirboLOX-C Cervical IBFD - M7391815512160

Anatomical Cage 16.5mm x 14mm x 12mm
CAPTIVA SPINE, INC.
18155-1216
In Commercial Distribution

  • M7391815512160 ()


  • Spinal fusion sphere

TirboLOX-C Cervical IBFD - M7391815512150

Anatomical Cage 15.5mm x 12mm x 12mm
CAPTIVA SPINE, INC.
18155-1215
In Commercial Distribution

  • M7391815512150 ()


  • Spinal fusion sphere

TirboLOX-C Cervical IBFD - M7391815512140

Anatomical Cage 14.5mm x 12mm x 12mm
CAPTIVA SPINE, INC.
18155-1214
In Commercial Distribution

  • M7391815512140 ()


  • Spinal fusion sphere

TirboLOX-C Cervical IBFD - M7391815511160

Anatomical Cage 16.5mm x 14mm x 11mm
CAPTIVA SPINE, INC.
18155-1116
In Commercial Distribution

  • M7391815511160 ()


  • Spinal fusion sphere

TirboLOX-C Cervical IBFD - M7391815511140

Anatomical Cage 14.5mm x 12mm x 11mm
CAPTIVA SPINE, INC.
18155-1114
In Commercial Distribution

  • M7391815511140 ()


  • Spinal fusion sphere
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