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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Polyaxial Screw 5.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-5535
In Commercial Distribution

  • 10889981015107 ()

  • 5.50mm x 35mm
10-12-5535

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 5.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-5525
In Commercial Distribution

  • 10889981015084 ()

  • 5.50mm x 25mm
10-12-5525

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4560
Not in Commercial Distribution

  • 10889981015060 ()

  • 4.75mm x 60mm
10-12-4560

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4550
In Commercial Distribution

  • 10889981015046 ()

  • 4.75mm x 50mm
10-12-4550

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4540
In Commercial Distribution

  • 10889981015022 ()

  • 4.75mm x 40mm
10-12-4540

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.75mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4530
In Commercial Distribution

  • 10889981015008 ()

  • 4.75mm x 30mm
10-12-4530

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4065
Not in Commercial Distribution

  • 10889981014988 ()

  • 4.00mm x 65mm
10-12-4065

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4055
Not in Commercial Distribution

  • 10889981014964 ()

  • 4.00mm x 55mm
10-12-4055

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4045
Not in Commercial Distribution

  • 10889981014940 ()

  • 4.00mm x 45mm
10-12-4045

  • Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 4.00mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
10-12-4030
In Commercial Distribution

  • 10889981014919 ()

  • 4.00mm x 30mm
10-12-4030

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 9.50mm x 95mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-9595
Not in Commercial Distribution

  • 10889981014896 ()

  • 9.50mm x 95mm
10-11-9595

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 9.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-9575
Not in Commercial Distribution

  • 10889981014872 ()

  • 9.50mm x 75mm
10-11-9575

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 9.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-9565
Not in Commercial Distribution

  • 10889981014858 ()

  • 9.50mm x 65mm
10-11-9565

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 9.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-9560
Not in Commercial Distribution

  • 10889981014841 ()

  • 9.50mm x 60mm
10-11-9560

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 9.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-9530
Not in Commercial Distribution

  • 10889981014797 ()

  • 9.50mm x 30mm
10-11-9530

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 9.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-9525
Not in Commercial Distribution

  • 10889981014780 ()

  • 9.50mm x 25mm
10-11-9525

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8590
Not in Commercial Distribution

  • 10889981014766 ()

  • 8.50mm x 90mm
10-11-8590

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 85mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8585
Not in Commercial Distribution

  • 10889981014759 ()

  • 8.50mm x 85mm
10-11-8585

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 80mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8580
Not in Commercial Distribution

  • 10889981014742 ()

  • 8.50mm x 80mm
10-11-8580

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8565
Not in Commercial Distribution

  • 10889981014711 ()

  • 8.50mm x 65mm
10-11-8565

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8555
Not in Commercial Distribution

  • 10889981014698 ()

  • 8.50mm x 55mm
10-11-8555

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8545
Not in Commercial Distribution

  • 10889981014674 ()

  • 8.50mm x 45mm
10-11-8545

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8535
Not in Commercial Distribution

  • 10889981014650 ()

  • 8.50mm x 35mm
10-11-8535

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 8.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-8525
Not in Commercial Distribution

  • 10889981014636 ()

  • 8.50mm x 25mm
10-11-8525

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7590
Not in Commercial Distribution

  • 10889981014612 ()

  • 7.50mm x 90mm
10-11-7590

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 85mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7585
Not in Commercial Distribution

  • 10889981014605 ()

  • 7.50mm x 85mm
10-11-7585

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7575
Not in Commercial Distribution

  • 10889981014582 ()

  • 7.50mm x 75mm
10-11-7575

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7565
Not in Commercial Distribution

  • 10889981014568 ()

  • 7.50mm x 65mm
10-11-7565

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7560
Not in Commercial Distribution

  • 10889981014551 ()

  • 7.50mm x 60mm
10-11-7560

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7555
Not in Commercial Distribution

  • 10889981014544 ()

  • 7.50mm x 55mm
10-11-7555

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7545
Not in Commercial Distribution

  • 10889981014520 ()

  • 7.50mm x 45mm
10-11-7545

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7535
Not in Commercial Distribution

  • 10889981014506 ()

  • 7.50mm x 35mm
10-11-7535

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 7.50mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-7525
Not in Commercial Distribution

  • 10889981014483 ()

  • 7.50mm x 25mm
10-11-7525

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 6.50mm x 90mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-6590
Not in Commercial Distribution

  • 10889981014469 ()

  • 6.50mm x 90mm
10-11-6590

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 6.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-6575
Not in Commercial Distribution

  • 10889981014438 ()

  • 6.50mm x 75mm
10-11-6575

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 6.50mm x 70mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-6570
Not in Commercial Distribution

  • 10889981014421 ()

  • 6.50mm x 70mm
10-11-6570

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 6.50mm x 60mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-6560
Not in Commercial Distribution

  • 10889981014407 ()

  • 6.50mm x 60mm
10-11-6560

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 6.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-6550
Not in Commercial Distribution

  • 10889981014384 ()

  • 6.50mm x 50mm
10-11-6550

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 6.50mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-6540
Not in Commercial Distribution

  • 10889981014360 ()

  • 6.50mm x 40mm
10-11-6540

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 6.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-6530
Not in Commercial Distribution

  • 10889981014346 ()

  • 6.50mm x 30mm
10-11-6530

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 5.50mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-5565
Not in Commercial Distribution

  • 10889981014322 ()

  • 5.50mm x 65mm
10-11-5565

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 5.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-5550
Not in Commercial Distribution

  • 10889981014292 ()

  • 5.50mm x 50mm
10-11-5550

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 5.50mm x 40mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-5540
Not in Commercial Distribution

  • 10889981014278 ()

  • 5.50mm x 40mm
10-11-5540

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 5.50mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-5530
Not in Commercial Distribution

  • 10889981014254 ()

  • 5.50mm x 30mm
10-11-5530

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 4.75mm x 65mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-4565
Not in Commercial Distribution

  • 10889981014230 ()

  • 4.75mm x 65mm
10-11-4565

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 4.75mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-4555
Not in Commercial Distribution

  • 10889981014216 ()

  • 4.75mm x 55mm
10-11-4555

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 4.75mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-4545
Not in Commercial Distribution

  • 10889981014193 ()

  • 4.75mm x 45mm
10-11-4545

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 4.75mm x 35mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-4535
Not in Commercial Distribution

  • 10889981014179 ()

  • 4.75mm x 35mm
10-11-4535

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 4.75mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-4525
Not in Commercial Distribution

  • 10889981014155 ()

  • 4.75mm x 25mm
10-11-4525

  • Bone-screw internal spinal fixation system, non-sterile
Non Self Tapping Fixed Screw 4.00mm x 55mm
SEASPINE ORTHOPEDICS CORPORATION
10-11-4055
Not in Commercial Distribution

  • 10889981014124 ()

  • 4.00mm x 55mm
10-11-4055

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