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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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Longbow, 13mm x 40mm x 0°
Life Spine, Inc.
85-1540-013X
In Commercial Distribution

  • 00190837022723 ()
85-1540-013X

  • Polymeric spinal interbody fusion cage
Longbow, 11mm x 40mm x 0°
Life Spine, Inc.
85-1540-011X
In Commercial Distribution

  • 00190837022716 ()
85-1540-011X

  • Polymeric spinal interbody fusion cage
Longbow, 9mm x 40mm x 0°
Life Spine, Inc.
85-1540-009X
In Commercial Distribution

  • 00190837022709 ()
85-1540-009X

  • Polymeric spinal interbody fusion cage
UNIPOLAR 14/16 TAPER SLEEVE + 0
Smith & Nephew, Inc.
126600
In Commercial Distribution

  • 03596010079633 ()
126600

  • Metallic femoral head prosthesis
Implant Caddy - 22mm X 0° Kit
PRECISION SPINE, INC.
60-BK-6001
In Commercial Distribution

  • 00840019936439 ()
60-BK-6001

  • Polymeric spinal interbody fusion cage
Implant Caddy - 18mm X 0° Kit
PRECISION SPINE, INC.
60-BK-6002
In Commercial Distribution

  • 00840019936446 ()
60-BK-6002

  • Polymeric spinal interbody fusion cage
Tibial Baseplate, Stemmed, Cemented, R, 0
Shalby Advanced Technologies, Inc.
2552-0-0000
In Commercial Distribution

  • 00840286824293 ()
2552-0-0000

  • Uncoated knee tibia prosthesis, metallic
Tibial Baseplate, Stemmed, Cemented, L, 0
Shalby Advanced Technologies, Inc.
2551-0-0000
In Commercial Distribution

  • 00840286824224 ()
2551-0-0000

  • Uncoated knee tibia prosthesis, metallic
Tibial Augment, Cemented, 0 L, 10mm
Shalby Advanced Technologies, Inc.
2440-0-1000
In Commercial Distribution

  • 00840286822893 ()
2440-0-1000

  • Uncoated knee tibia prosthesis, metallic
Tibial Augment, Cemented, 0 L, 5mm
Shalby Advanced Technologies, Inc.
2440-0-0500
In Commercial Distribution

  • 00840286822817 ()
2440-0-0500

  • Uncoated knee tibia prosthesis, metallic
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