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Bio Plug 163015

by Biomet Orthopedics, Inc.

Bio Plug 163015 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K800144 on 19 Feb 1980 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304004085), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K800144

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304004085 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK800144 Date19 Feb 1980DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K800144 decided 19 Feb 1980 Active
  • FDA GUDID UDI-DI 00880304004085 listed 24 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1858-2017 FDA Class II initiated 17 Feb 2017

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Timeline

3 dated events

  1. Cleared FDA 510(k) K800144
  2. Listed FDA GUDID 00880304004085
  3. Recall initiated FDA recalls Z-1858-2017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bio Plug
Generic name
Polymer orthopaedic cement restrictor, non-bioabsorbable
Model / Ref / Catalog
163015
Primary DI / UDI-DI
00880304004085
510(k) Number
FDA product code
JDS
GMDN term
Polymer orthopaedic cement restrictor, non-bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polymer orthopaedic cement restrictor, non-bioabsorbable

Cleared under the same submission (K800144)

and 6 more cleared under K800144

Similar devices

Other devices filed under FDA product code JDS (NAIL, FIXATION, BONE).

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)