Na 02.231.010S

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	Number10886982061829 UDI-DI	Date14 Sep 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

- Terminated Z-1125-2014 FDA Class II initiated 5 Feb 2014
Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).
- Terminated Z-0401-2014 FDA Class II initiated 29 May 2013
A plate was inadvertently released to a sales consultant that was restricted for sale.

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Withdrawn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: 02.231.010S, 02231010S

Primary DI / UDI-DI: 10886982061829
510(k) Number: K110354
FDA Product Code: HRS, JDP, HWC
GMDN Term: Orthopaedic bone screw (non-sliding)

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

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (8)

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