Laboratoires Bodycad Inc

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopaedic Surgical Planning And Instrument Guides (PBF) (8) Plate, Fixation, Bone (HRS) (8) Screw, Fixation, Bone (HWC) (8) Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (HSX) (2)

Premarket Exempt

No Yes

Clear

Fine Osteotomy implants - Proximal tibia - 00688346002348 Catalog Number : 015-410-103

Device Description : Tibial plate, cancellous compression screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine Osteotomy implants - Proximal tibia - 00688346002355 Catalog Number : 015-410-104

Device Description : Tibial plate, cortical locking screws, cortical compression screws, cancellous Tibial plate, cortical locking screws, cortical compression screws, cancellous compression screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : No

Device Count : 1

Fine Osteotomy implants - Proximal tibia - 00688346002362 Catalog Number : 015-410-105

Device Description : Tibial plate, cortical compression screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine Osteotomy implants - Proximal tibia - 00688346002379 Catalog Number : 015-410-106

Device Description : Tibial plate, cortical locking screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : No

Device Count : 1

Fine Osteotomy implants - Proximal tibia - 00688346002386 Catalog Number : 015-410-107

Device Description : Tibial plate, cortical locking screws , cortical compression screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : No

Device Count : 1

Fine Osteotomy disposable instruments - Proximal tibia - 00688346002393 Catalog Number : 015-410-601

Device Description : Cutting guides, drilling towers, pre-drill guide, open validators and retaining screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : No

Device Count : 1

Fine Osteotomy disposable instruments - Proximal tibia - 00688346002409 Catalog Number : 015-410-602

Device Description : Cutting guides, drilling tower, Open validators and retaining screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : No

Device Count : 1

Fine Osteotomy disposable instruments - Proximal tibia - 00688346002416 Catalog Number : 015-410-603

Device Description : Cutting guides, drilling towers and retaining screws

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : No

Device Count : 1

BC Reflex Uni Reusable Surgical Instrument Set - 00688346002478 Catalog Number : 027-003

Device Description : Reusable Surgical Instrument Set

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HSX

Prescription Use : Yes

Device Count : 1

Bodycad Unicompartmental Knee System - 00688346010008 Catalog Number : 010003

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HSX

Prescription Use : Yes

Device Count : 1

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