Exactech

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Exactech FDA UDI
Generic Name: Ceramic femoral head prosthesis FDA UDI
Model / Reference: 170-40-07 FDA UDI

Identifiers

Catalog Number: 170-40-07 FDA UDI
Primary DI / UDI-DI: 10885862155542 FDA UDI
510(k) Number: K121392 FDA UDI
FDA Product Code: MEH FDA UDI
LZO FDA UDI
LWJ FDA UDI
LPH FDA UDI
JDI FDA UDI
GMDN Term: Ceramic femoral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3360 FDA UDI
888.3358 FDA UDI
888.3350 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 40 Millimeter FDA UDI

Category: Ceramic femoral head prosthesis

Exactech by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ceramic femoral head prosthesis.

Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
ELEC(R)plus — HiPer Medical AG · Class III
BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
InSitu Hip System — Nextstep Arthropedix · Class II
Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
InSitu Hip System — Nextstep Arthropedix · Class II
SYNERGY — Smith & Nephew, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II

Cleared under the same submission

K121392 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

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Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 3f7ff6a2-ead8-4726-9bbd-15db85400553 35 fields · synced May 30, 2026