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Fine Osteotomy disposable instruments - Proximal tibia

FDA UDI

Class II (US FDA UDI)

by Laboratoires Bodycad Inc

Identity

Trade Name
Fine Osteotomy disposable instruments - Proximal tibia FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Proximal tibia, disposable instruments (cutting guides, screws, drilling tower) FDA UDI
Model / Reference
015-410-603 FDA UDI
Description
Proximal tibia, disposable instruments (cutting guides, screws, drilling tower) FDA UDI

Identifiers

Catalog Number
015-410-603 FDA UDI
Primary DI / UDI-DI
00688346000559 FDA UDI
510(k) Number
K193614 FDA UDI
FDA Product Code
HWC FDA UDI
PBF FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

Fine Osteotomy disposable instruments - Proximal tibia by Laboratoires Bodycad Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Cleared under the same submission

K193614 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laboratoires Bodycad Inc

Sources (1)

  • FDA UDI 3c130fe8-d311-446b-ab59-372dfcb724ce 35 fields · synced May 30, 2026