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Summit Patella Plating System Standard

by Endeavor Orthopaedics, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860004838005 UDI-DI Date3 Mar 2022ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Summit Patella Plating System
Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
Standard, 1316-3000
Primary DI / UDI-DI
00860004838005
510(k) Number
FDA Product Code
HRS, GAT
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3030, 878.5000
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K203408)

Other devices from Endeavor Orthopaedics, LLC

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

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