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Mountaineer 288320201

by Depuy Spine, Inc.

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

Overview

The MOUNTAINEER laminoplasty system plate bending iron, thru is a medical device designed for manual orthopaedic benders. This device is typically used in orthopedic surgery to bend orthopaedic devices, such as rods and plates, to an appropriate anatomical shape. It is a reusable instrument that can be hand held or table mounted.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034221946 UDI-DI Date31 Dec 2016ListedStatusListed 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  • Withdrawn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
Mountaineer
Generic Name
Manual orthopaedic bender, reusable
Model / Ref / Catalog
288320201
Primary DI / UDI-DI
10705034221946
FDA Product Code
HXW
GMDN Term
Manual orthopaedic bender, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Depuy Spine, Inc.

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No