← Back to catalogue

T-Fix

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
T-FIX FDA UDI
Generic Name
Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
T-FIX RCG DRILL PAC, STERILE, WITH 1 DRILL AND 2 SLEEVES FDA UDI
Model / Reference
014771 FDA UDI
Description
T-FIX RCG DRILL PAC, STERILE, WITH 1 DRILL AND 2 SLEEVES FDA UDI

Identifiers

Catalog Number
014771 FDA UDI
Primary DI / UDI-DI
03596010446114 FDA UDI
510(k) Number
K925573 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Arthroscopic surgical procedure kit, non-medicated, single-use

T-Fix by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic surgical procedure kit, non-medicated, single-use.

Cleared under the same submission

K925573 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
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI a89da457-4e0e-4310-86db-4dd3680ba896 36 fields · synced Jun 8, 2026