Skip to content

A.l.p.s.® Proximal Humerus Plating Systemshoulder Plate Depth Gauge Hook 110017635

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

18 closed

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 Number00887868135088 UDI-DI Date23 Mar 2016ListedStatusListed GUDID: in commercial distribution

Recalls

18 recalls · FDA

  • 18 recalls, same reason

    • Terminated Z-2313-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2306-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2321-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2312-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2315-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2309-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2316-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2318-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2307-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2319-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2320-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2324-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2314-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2323-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2305-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2311-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2317-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2322-2020 FDA Class II initiated 14 May 2020

    Distributed to the field without having completed design history files or design transfer activities

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
A.l.p.s.® Proximal Humerus Plating Systemshoulder Plate Depth Gauge Hook
Generic Name
Surgical depth gauge, reusable
Model / Ref / Catalog
110017635
Primary DI / UDI-DI
00887868135088
510(k) Number
FDA Product Code
HRS
GMDN Term
Surgical depth gauge, reusable
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical depth gauge, reusable

Cleared under the same submission (K143697)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

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