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) (10) Screw, Fixation, Bone (HWC) (10) Plate, Fixation, Bone (HRS) (9) Unit, Traction, Hip, Non-Powered, Non-Penetrating (HSR) (1)

Premarket Exempt

No Yes

Clear

Fine Osteotomy system - Distal femur - 00688346002133 Catalog Number : 015-330-006

Device Description : Femoral plate, cortical locking screws and disposable instrument

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine Osteotomy system - Distal femur - 00688346002140 Catalog Number : 015-330-007

Device Description : Femoral plate , Cortical Locking Screws, Cortical Compression Screws and disposa Femoral plate , Cortical Locking Screws, Cortical Compression Screws and disposable instrument

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine Osteotomy implants - Distal femur - 00688346002157 Catalog Number :

Device Description : Femoral plate, 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 - Distal femur - 00688346002164 Catalog Number : 015-330-102

Device Description : Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws

Device Class : 1

Duns Number: 202981171

Premarket Exempt : No

Product Code : HSR, HWC, PBF

Prescription Use : No

Device Count : 1

Fine Osteotomy implants - Distal femur - 00688346002188 Catalog Number : 015-330-104

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : No

Device Count : 1

Fine Osteotomy system - Distal femur - 00688346002195 Catalog Number :

Device Description : Femoral 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 system - Distal femur - 00688346002201 Catalog Number : 015-330-106

Device Description : Femoral 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 system - Distal femur - 00688346002218 Catalog Number :

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

Device Class : 2

Duns Number: 202981171

Premarket Exempt : No

Product Code : HRS, HWC, PBF

Prescription Use : Yes

Device Count : 1

Fine Osteotomy disposable instruments - Distal femur - 00688346002225 Catalog Number : 015-330-601

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 - Distal femur - 00688346002232 Catalog Number :

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 : Yes

Device Count : 1

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