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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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USTAR II Knee System - 04711605589871

Set screw driver adaptor, T8
UNITED ORTHOPEDIC CORP.
9315-5101-RB
In Commercial Distribution

  • 04711605589871 ()


  • Orthopaedic implant-instrument extension adaptor, reusable

USTAR II Knee System - 04711605589864

Driver handle, 1/4", SQ
UNITED ORTHOPEDIC CORP.
9315-1103
In Commercial Distribution

  • 04711605589864 ()


  • Surgical instrument handle, non-torque-limiting

"USTAR II Knee System " - 04711605589543

USTAR II Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9415-5005
In Commercial Distribution

  • 04711605589543 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

USTAR II Knee System - 04711605589178

Femoral driver
UNITED ORTHOPEDIC CORP.
9315-5110
In Commercial Distribution

  • 04711605589178 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

USTAR II Knee System - 04711605589925

Insert screw driver adaptor
UNITED ORTHOPEDIC CORP.
9315-5106
In Commercial Distribution

  • 04711605589925 ()


  • Orthopaedic implant-instrument extension adaptor, reusable

USTAR II Knee System - 04711605589536

USTAR II Tibial baseplate trial driver
UNITED ORTHOPEDIC CORP.
9415-5004
In Commercial Distribution

  • 04711605589536 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

USTAR II Knee System - 04711605584982

Screw driver adaptor, T30
UNITED ORTHOPEDIC CORP.
9415-5101
In Commercial Distribution

  • 04711605584982 ()
9415-5101

  • Surgical screwdriver, reusable

U2 Total Knee System - 04711605583763

Femoral driver
UNITED ORTHOPEDIC CORP.
9303-5110-RT
In Commercial Distribution

  • 04711605583763 ()
9303-5110-RT

  • Orthopaedic inorganic implant inserter/extractor, reusable

UKNEE Total Knee System - 04711605582674

Slide hammer assembly
UNITED ORTHOPEDIC CORP.
9301-5105
In Commercial Distribution

  • 04711605582674 ()
9301-5105

  • Surgical mallet

Orthopedic manual surgical instrument - 04718005159871

Comet Lumbar Implant Driver
BAUI BIOTECH CO. LTD.
420-1724
In Commercial Distribution

  • 04718005159871 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Orthopedic manual surgical instrument - 04718005155231

3mm Hex Screw Driver
BAUI BIOTECH CO. LTD.
406-0830A
In Commercial Distribution

  • 04718005155231 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404335

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404328

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9905.0014.11S
In Commercial Distribution

  • 14717002404325 ()
  • 04717002404328 ()
  • 24717002404322 ()
9905.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Quantum® Spinal Fixation System - 00846468022297

DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022181

DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021610

DRIVER, ROD TO ROD
Pioneer Surgical Technology, Inc.
10-RDDRIVER
Not in Commercial Distribution

  • 00846468021610 ()


  • General internal orthopaedic fixation system implantation kit

Cequence Anterior Cervical Plate - 00846468018535

Modular Screw Driver Shaft I w/AO Fitting
Pioneer Surgical Technology, Inc.
0259-0001
Not in Commercial Distribution

  • 00846468018535 ()
0259-0001

  • Spinal fixation plate, non-bioabsorbable

Medtronic Reusable Instruments - 00613994947932

DRIVER EX0111002 T27
MEDTRONIC SOFAMOR DANEK, INC.
EX0111002
In Commercial Distribution

  • 00613994947932 ()


  • Surgical drill guide, reusable

N/A - 00613994946652

DRIVER 5484339 DUAL PURPOSE DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5484339
In Commercial Distribution

  • 00613994946652 ()


  • Orthopaedic implant driver

N/A - 00613994946614

STARTER 5484338 NON-BREAKOFF PLUG
MEDTRONIC SOFAMOR DANEK, INC.
5484338
In Commercial Distribution

  • 00613994946614 ()


  • Orthopaedic implant driver
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