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Nexel®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
Nexel® FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Model / Reference
47-8401-038-00 FDA UDI

Identifiers

Catalog Number
47-8401-038-00 FDA UDI
Primary DI / UDI-DI
00889024274327 FDA UDI
510(k) Number
K150501 FDA UDI
FDA Product Code
JDC FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

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

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Cleared under the same submission

K150501 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 27aef301-c761-48e4-9ca3-e0b9c58c3815 35 fields · synced Jun 7, 2026