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Fine osteotomy HB 6.5 Cancellous Bone Screw - L35mm

FDA UDI

Class II (US FDA UDI)

by Laboratoires Bodycad Inc

Identity

Trade Name
Fine osteotomy HB 6.5 Cancellous Bone Screw - L35mm FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
Button Head Spherical Seat HB 6.5 Cancellous Bone Screw - L35mm FDA UDI
Model / Reference
037-112-035 FDA UDI
Description
Button Head Spherical Seat HB 6.5 Cancellous Bone Screw - L35mm FDA UDI

Identifiers

Primary DI / UDI-DI
00688346002959 FDA UDI
510(k) Number
K231314 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Fine osteotomy HB 6.5 Cancellous Bone Screw - L35mm by Laboratoires Bodycad Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Cleared under the same submission

K231314 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 ec62a6ee-e698-463f-81e4-a0c0108bb350 34 fields · synced Jun 6, 2026