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Unicondylar Interpositional Spacer

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
Unicondylar Interpositional Spacer FDA UDI
Generic Name
Orthopaedic retractor FDA UDI
Model / Reference
82-0153-115-01 FDA UDI

Identifiers

Catalog Number
82-0153-115-01 FDA UDI
Primary DI / UDI-DI
00889024487031 FDA UDI
510(k) Number
K003269 FDA UDI
FDA Product Code
HSH FDA UDI
GMDN Term
Orthopaedic retractor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3590 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic retractor

Unicondylar Interpositional Spacer by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic retractor.

Cleared under the same submission

K003269 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer, Inc.

Sources (1)

  • FDA UDI facbed47-8b4a-436c-8f8b-74f78653c69d 36 fields · synced May 30, 2026