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Arcos Modular Revision System 31-301335

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304490000 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Arcos Modular Revision System
Generic Name
Femoral stem prosthesis trial
Model / Ref / Catalog
31-301335
Primary DI / UDI-DI
00880304490000
510(k) Number
FDA Product Code
LZO, KWY, JDI, MAY, KWZ, MEH, LPH
GMDN Term
Femoral stem prosthesis trial
Device Class
Class II
Regulation Number
888.3353, 888.3390, 888.3350, 888.3310, 888.3358
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Femoral stem prosthesis trial

Cleared under the same submission (K100469)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No