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Stapix Superelastic Nitinol Staple System SK141614

by Restore Surgical LLC GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10815375021782 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  • Withdrawn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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Stapix Superelastic Nitinol Staple System
Generic Name
Orthopaedic bone staple, non-adjustable
Model / Reference
SK141614
Primary DI / UDI-DI
10815375021782
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