Exactech

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Exactech FDA UDI
Generic Name: Polyethylene acetabulum prosthesis FDA UDI
Model / Reference: 106-28-50 FDA UDI

Identifiers

Catalog Number: 106-28-50 FDA UDI
Primary DI / UDI-DI: 10885862014610 FDA UDI
510(k) Number: K963313 FDA UDI
FDA Product Code: JDI FDA UDI
GMDN Term: Polyethylene acetabulum prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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 — 50 Millimeter FDA UDI
Lumen/Inner Diameter — 28 Millimeter FDA UDI

Category: Polyethylene acetabulum prosthesis

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

Similar devices

Also classified as Polyethylene acetabulum prosthesis.

ZCA® — Zimmer, Inc. · Class II
Acetabular Insert — Howmedica Osteonics Corp. · Class II
Cenator Total Hip System — CORIN LTD · Class II
Exeter — Howmedica Osteonics Corp. · Class II
Exeter — Howmedica Osteonics Corp. · Class II
ZCA® — Zimmer, Inc. · Class II
REFLECTION — Smith & Nephew, Inc. · Class II
ZCA® — Zimmer, Inc. · Class II

Cleared under the same submission

K963313 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 b7ce4bbe-b9fc-432e-9703-945db0d25b31 35 fields · synced May 30, 2026