Na 2347-126-10

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889024053694 UDI-DI	Date9 Oct 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

2 recalls, same reason
- Terminated Z-0315-2020 FDA Class II initiated 10 Oct 2019
- Terminated Z-0307-2020 FDA Class II initiated 10 Oct 2019
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog: 2347-126-10, 00-2347-126-10

Primary DI / UDI-DI: 00889024053694
510(k) Number: K142579
FDA Product Code: HWC, HRS
GMDN Term: Orthopaedic bone screw (non-sliding)

Device Class: Class II
Regulation Number: 888.3040, 888.3030
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Length — 110 Millimeter

Other devices from Zimmer, Inc.

IDENTITY Humeral 120001790

Class I
IDENTITY Humeral 120001792

Class I
IDENTITY Humeral 120001791

Class I
IDENTITY Humeral 120001795

Class I
IDENTITY Humeral 120001793

Class I
Comprehensive Humeral 120001798

Class I

See all devices from Zimmer, Inc. →

Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No