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Na 487.995

by Synthes GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10887587056050 UDI-DIDate14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

1 recall · FDA

    • Terminated Z-0942-2013 FDA Class II initiated 11 Jan 2013

    There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.

Specification

GUDID

Generic Name
Implantable craniofacial bone distractor
Model / Ref / Catalog
487.995, 487995
Primary DI / UDI-DI
10887587056050
510(k) Number
FDA Product Code
JEY
GMDN Term
Implantable craniofacial bone distractor
Device Class
Class II
Regulation Number
872.4760
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Implantable craniofacial bone distractor

Cleared under the same submission (K010499)

Show all (9)

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