← Back to catalogue

Nexel™

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
Nexel™ FDA UDI
Generic Name
Hinged total elbow prosthesis FDA UDI
Model / Reference
00-8400-090-00 FDA UDI

Identifiers

Catalog Number
00-8400-090-00 FDA UDI
Primary DI / UDI-DI
00889024271449 FDA UDI
510(k) Number
K123862 FDA UDI
FDA Product Code
JDC FDA UDI
GMDN Term
Hinged total elbow prosthesis 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

Yes

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: Hinged total elbow prosthesis

Nexel is a hinged total elbow prosthesis designed for individuals with damaged or degenerative joint articulation. This sterile implantable artificial substitute features humeral and ulnar components made of metal and polyethylene, along with fixation devices for optimal stability. The device may be implanted in conjunction with bone cement for added security.

Similar devices

Also classified as Hinged total elbow prosthesis.

Cleared under the same submission

K123862 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Zimmer, Inc.

Sources (1)

  • FDA UDI 4265d259-5134-4cd8-8ec3-0fa3da864083 35 fields · synced Jun 22, 2026