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 Type Device Class Implantable

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Newport 4.75 X 50mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4750
In Commercial Distribution

  • 10889981138813 ()

  • 4.75 X 50mm
61-4750

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 45mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4745
In Commercial Distribution

  • 10889981138806 ()

  • 4.75 X 45mm
61-4745

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 40mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4740
In Commercial Distribution

  • 10889981138790 ()

  • 4.75 X 40mm
61-4740

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 35mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4735
In Commercial Distribution

  • 10889981138783 ()

  • 4.75 X 35mm
61-4735

  • Spinal bone screw, non-bioabsorbable
Newport 4.75 X 30mm Double Lead Screw
SEASPINE ORTHOPEDICS CORPORATION
61-4730
In Commercial Distribution

  • 10889981138776 ()

  • 4.75 X 30mm
61-4730

  • Spinal bone screw, non-bioabsorbable
Inner Tray Lid
SEASPINE ORTHOPEDICS CORPORATION
91-7284
In Commercial Distribution

  • 10889981221492 ()
91-7284

  • Instrument tray, reusable
Malibu Implant Tray Lid
SEASPINE ORTHOPEDICS CORPORATION
91-7283
In Commercial Distribution

  • 10889981221485 ()
91-7283

  • Instrument tray, reusable
Malibu Implant Tray 1 Inner Tray 2
SEASPINE ORTHOPEDICS CORPORATION
91-7282
In Commercial Distribution

  • 10889981221478 ()
91-7282

  • Instrument tray, reusable
Malibu Implant Tray 1 Inner Tray 1
SEASPINE ORTHOPEDICS CORPORATION
91-7281
In Commercial Distribution

  • 10889981221461 ()
91-7281

  • Instrument tray, reusable
Malibu Implant Tray
SEASPINE ORTHOPEDICS CORPORATION
91-7280
In Commercial Distribution

  • 10889981221454 ()
91-7280

  • Instrument tray, reusable
Malibu Instrument Tray 2 Inner Tray 2
SEASPINE ORTHOPEDICS CORPORATION
91-7275
In Commercial Distribution

  • 10889981221423 ()
91-7275

  • Instrument tray, reusable
Malibu Instrument Tray 2 Base
SEASPINE ORTHOPEDICS CORPORATION
91-7273
In Commercial Distribution

  • 10889981221409 ()
91-7273

  • Instrument tray, reusable
Malibu Instrument Tray 1 Inner Tray 2
SEASPINE ORTHOPEDICS CORPORATION
91-7272
In Commercial Distribution

  • 10889981221393 ()
91-7272

  • Instrument tray, reusable
Malibu Instrument Tray 1 Inner Tray 1
SEASPINE ORTHOPEDICS CORPORATION
91-7271
In Commercial Distribution

  • 10889981221386 ()
91-7271

  • Instrument tray, reusable
Malibu Instrument Tray 1 Base
SEASPINE ORTHOPEDICS CORPORATION
91-7270
In Commercial Distribution

  • 10889981221379 ()
91-7270

  • Instrument tray, reusable
Polyaxial Reduction Screw, SS, 8.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8565
In Commercial Distribution

  • 10889981025519 ()

  • 8.50mm x 65mm
25-32-8565

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8560
In Commercial Distribution

  • 10889981025502 ()

  • 8.50mm x 60mm
25-32-8560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8555
Not in Commercial Distribution

  • 10889981025496 ()

  • 8.50mm x 55mm
25-32-8555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8550
In Commercial Distribution

  • 10889981025489 ()

  • 8.50mm x 50mm
25-32-8550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8545
In Commercial Distribution

  • 10889981025472 ()

  • 8.50mm x 45mm
25-32-8545

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8540
In Commercial Distribution

  • 10889981025465 ()

  • 8.50mm x 40mm
25-32-8540

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8535
In Commercial Distribution

  • 10889981025458 ()

  • 8.50mm x 35mm
25-32-8535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8530
In Commercial Distribution

  • 10889981025441 ()

  • 8.50mm x 30mm
25-32-8530

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 8.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-8525
In Commercial Distribution

  • 10889981025434 ()

  • 8.50mm x 25mm
25-32-8525

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 95mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7595
In Commercial Distribution

  • 10889981025427 ()

  • 7.50mm x 95mm
25-32-7595

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7590
In Commercial Distribution

  • 10889981025410 ()

  • 7.50mm x 90mm
25-32-7590

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 85mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7585
In Commercial Distribution

  • 10889981025403 ()

  • 7.50mm x 85mm
25-32-7585

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 80mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7580
In Commercial Distribution

  • 10889981025397 ()

  • 7.50mm x 80mm
25-32-7580

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7575
In Commercial Distribution

  • 10889981025380 ()

  • 7.50mm x 75mm
25-32-7575

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 70mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7570
In Commercial Distribution

  • 10889981025373 ()

  • 7.50mm x 70mm
25-32-7570

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7565
In Commercial Distribution

  • 10889981025366 ()

  • 7.50mm x 65mm
25-32-7565

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7560
In Commercial Distribution

  • 10889981025359 ()

  • 7.50mm x 60mm
25-32-7560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7555
In Commercial Distribution

  • 10889981025342 ()

  • 7.50mm x 55mm
25-32-7555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7550
In Commercial Distribution

  • 10889981025335 ()

  • 7.50mm x 50mm
25-32-7550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7545
In Commercial Distribution

  • 10889981025328 ()

  • 7.50mm x 45mm
25-32-7545

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7540
In Commercial Distribution

  • 10889981025311 ()

  • 7.50mm x 40mm
25-32-7540

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7535
In Commercial Distribution

  • 10889981025304 ()

  • 7.50mm x 35mm
25-32-7535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7530
In Commercial Distribution

  • 10889981025298 ()

  • 7.50mm x 30mm
25-32-7530

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 7.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-7525
In Commercial Distribution

  • 10889981025281 ()

  • 7.50mm x 25mm
25-32-7525

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6565
In Commercial Distribution

  • 10889981025274 ()

  • 6.50mm x 65mm
25-32-6565

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6560
In Commercial Distribution

  • 10889981025267 ()

  • 6.50mm x 60mm
25-32-6560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6555
In Commercial Distribution

  • 10889981025250 ()

  • 6.50mm x 55mm
25-32-6555

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6550
In Commercial Distribution

  • 10889981025243 ()

  • 6.50mm x 50mm
25-32-6550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6545
In Commercial Distribution

  • 10889981025236 ()

  • 6.50mm x 45mm
25-32-6545

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6540
In Commercial Distribution

  • 10889981025229 ()

  • 6.50mm x 40mm
25-32-6540

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6535
In Commercial Distribution

  • 10889981025212 ()

  • 6.50mm x 35mm
25-32-6535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6530
In Commercial Distribution

  • 10889981025205 ()

  • 6.50mm x 30mm
25-32-6530

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 6.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-6525
In Commercial Distribution

  • 10889981025199 ()

  • 6.50mm x 25mm
25-32-6525

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 5.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-5565
In Commercial Distribution

  • 10889981025182 ()

  • 5.50mm x 65mm
25-32-5565

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Reduction Screw, SS, 5.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
25-32-5560
In Commercial Distribution

  • 10889981025175 ()

  • 5.50mm x 60mm
25-32-5560

  • Bone-screw internal spinal fixation system, non-sterile
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