Femoral Stem Impactor with Anteversion

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name: Femoral Stem Impactor with Anteversion FDA UDI
Generic Name: Orthopaedic implant impactor, reusable FDA UDI
Device Name: Femoral Stem Impactor with Anteversion FDA UDI
Model / Reference: 1307.00.000 FDA UDI
Description: Femoral Stem Impactor with Anteversion FDA UDI

Identifiers

Primary DI / UDI-DI: 00819251021197 FDA UDI
FDA Product Code: HWA FDA UDI
GMDN Term: Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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 implant impactor, reusable

Femoral Stem Impactor with Anteversion by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant impactor, reusable.

TRIAL COVERING INSERT Ø32 48 — groupe lépine · Class IIa
MobiliT Cup — CORIN LTD · Class II
R3 — Smith & Nephew, Inc. · Class II
TRIAL COVERING INSERT Ø28 39 — groupe lépine · Class IIa
MobiliT Cup — CORIN LTD · Class II
KMEDIC — TELEFLEX INCORPORATED · Class I
TRIAL COVER INSERT Ø28 36 — groupe lépine · Class IIa
R3 — Smith & Nephew, Inc. · Class I

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 I	Pending data

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

Manufacturer

Manufacturer: Total Joint Orthopedics, Inc.

Sources (1)

FDA UDI d22d402f-c86c-4d23-9761-a1de73c39b8d 35 fields · synced Jun 1, 2026