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

Screw, Fixation, Bone (HWC) (7) Orthopaedic Surgical Planning And Instrument Guides (PBF) (5) Plate, Fixation, Bone (HRS) (5) Orthopedic Manual Surgical Instrument (LXH) (1) Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (HSX) (1) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

No Yes

Clear

Fine Osteotomy Reusable Surgical Instruments Set - 00688346000016 Catalog Number : 025-002

Device Class : 1

Duns Number: 202981171

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Fine Osteotomy system - Proximal tibia - 00688346000047 Catalog Number : 015-410-001

Device Description : Proximal tibia, plate, screws (compression cortical/cancellous), guides

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

BC Reflex Uni - 00688346000061 Catalog Number : 018-001

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HSX

Prescription Use : Yes

Device Count : 1

Fine Osteotomy system - Distal femur - 00688346000078 Catalog Number : 015-330-001

Device Description : Distal femur, plate, screws (compression cortical/cancellous), guides

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine Osteotomy Implant and Disposable Instrumentation Tray - 00688346000085 Catalog Number : 025-004

Device Class : 1

Duns Number: 202981171

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Fine Osteotomy implants - Distal femur - 00688346000108 Catalog Number : 015-330-101

Device Description : Distal femur, plate, screws (cortical/cancellous compression)

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Fine Osteotomy disposable instruments - Distal femur - 00688346000115 Catalog Number : 015-330-601

Device Description : Distal femur, disposable instruments (cutting guides, screws, drilling tower, pr Distal femur, disposable instruments (cutting guides, screws, drilling tower, pre-drill guide, validators)

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine Osteotomy implants - Proximal tibia - 00688346000122 Catalog Number : 015-410-101

Device Description : Proximal tibia, plate, screws (cortical/cancellous compression)

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Fine Osteotomy disposable instruments - Proximal tibia - 00688346000139 Catalog Number : 015-410-601

Device Description : Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, pre-drill guide, validators)

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine osteotomy System - 00688346000191 Catalog Number : 025-006

Device Description : Implant-Screw Caddy

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

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