← Back to catalogue

CoLag™

FDA UDI

Class II (US FDA UDI)

by In2Bones, USA

Identity

Trade Name
CoLag™ FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
SCREW, FT, Ø6.7X32.0 mm FDA UDI
Model / Reference
P65 ST832 FDA UDI
Description
SCREW, FT, Ø6.7X32.0 mm FDA UDI

Identifiers

Catalog Number
P65 ST832 FDA UDI
Primary DI / UDI-DI
00817906023862 FDA UDI
510(k) Number
K170518 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bone screw (non-sliding)

CoLag is a small, threaded, non-bioabsorbable implantable rod used for internal orthopaedic fixation in bones such as the femur, rib, sternum, and pelvis. It is designed to hold plates, nails, rods, or prostheses in place and provide direct interfragmentary stabilization of fractured bones.

Similar devices

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

Cleared under the same submission

K170518 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
In2Bones, USA

Sources (1)

  • FDA UDI 54a57fc1-1122-4b12-b2c9-840eeb4d7358 36 fields · synced Jul 29, 2026