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Na 497.878

by Synthes (U.S.a.) LP

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number10705034788524 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
497.878, 497878
Primary DI / UDI-DI
10705034788524
FDA Product Code
KWQ, MNI, NKB, KWP, MNH
GMDN Term
Bone-screw internal spinal fixation system, non-sterile
Device Class
Class II
Regulation Number
888.3060, 888.3070, 888.3050
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Synthes (U.S.a.) LP

See all devices from Synthes (U.S.a.) LP →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: 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