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Foundation Surgical Instruments FS50-010000

by Foundation Surgical Group GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810141040007 UDI-DIDate5 Mar 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Foundation Surgical Instruments
Generic Name
Surgical implant/trial-implant/sizer holder, reusable
Model / Ref / Catalog
FS50-010000
Primary DI / UDI-DI
00810141040007
510(k) Number
FDA Product Code
OVD
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable
Device Class
Class II
Regulation Number
888.3080
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K241487)

Show all (12)

Other devices from Foundation Surgical Group

See all devices from Foundation Surgical Group →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: 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