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Stapix Superelastic Nitinol Staple System SK161414

by Restore Surgical LLC

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 Number10815375021690 UDI-DIDate17 Oct 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  • Withdrawn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

Trade Name
Stapix Superelastic Nitinol Staple System
Generic Name
Orthopaedic bone staple, non-adjustable
Model / Reference
SK161414
Primary DI / UDI-DI
10815375021690
FDA Product Code
JDR
GMDN Term
Orthopaedic bone staple, non-adjustable
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
Not in Commercial Distribution

Other devices from Restore Surgical LLC

Properties

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

Other properties (9)

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