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Na 459.50

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number10886982231574 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2243-2013 FDA Class II initiated 18 Apr 2013

    Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Orthopaedic bone bolt
Model / Ref / Catalog
459.50, 45950
Primary DI / UDI-DI
10886982231574
510(k) Number
FDA Product Code
HSB, JDS, JDN, HTY, JDW
GMDN Term
Orthopaedic bone bolt
Device Class
Class II
Regulation Number
888.3020, 888.3030, 888.3060, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Category: Orthopaedic bone bolt

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Other devices from Synthes

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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