Tomofix

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: TOMOFIX FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: TI TOMOFIX MEDIAL DISTAL FEMUR PLATE - 4 HOLES/RIGHT FDA UDI
Model / Reference: 04.120.550 FDA UDI
Description: TI TOMOFIX MEDIAL DISTAL FEMUR PLATE - 4 HOLES/RIGHT FDA UDI

Identifiers

Catalog Number: 04120550 FDA UDI
Primary DI / UDI-DI: 10886982109668 FDA UDI
510(k) Number: K141796 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Tomofix by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic fixation plate, non-bioabsorbable.

Peri-Loc — Smith & Nephew, Inc. · Class II
Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
AXSOS — Stryker Corp. · Class II
Xpert Wrist — NEWCLIP TECHNICS · Class II
ACUMED — ACUMED LLC · Class II
Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II

Cleared under the same submission

K141796 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Synthes

Sources (1)

FDA UDI 9f3eff0e-92e0-4d37-ac8b-b76b97b47d8b 36 fields · synced May 30, 2026