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Na 04.617.812

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034742250 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-0104-2012 FDA Unclassified (pre-2012) initiated 23 Sep 2011 on shared 510(k) K072981

    LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.

    • Terminated Z-1348-2009 FDA Unclassified (pre-2012) initiated 10 Feb 2009 on shared 510(k) K072981

    Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
04.617.812, 04617812
Primary DI / UDI-DI
10705034742250
510(k) Number
FDA Product Code
OVE, KWQ
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3080, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K072981)

Show all (12)

Cleared under the same submission (K152239)

Show all (12)

Other devices from Synthes

See all devices from Synthes →

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