Skip to content

Biocomposites 990-001

by Micromedics, Inc.

Biocomposites 990-001 is a bone graft delivery kit (FDA Class II; FDA product code FMF, Syringe, Piston) made by Micromedics, Inc., cleared under FDA 510(k) K151543 on 7 Jul 2015 and listed in FDA GUDID since 23 Apr 2021 (UDI-DI 00815634020894), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K151543

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815634020894 UDI-DI Date23 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK151543 Date7 Jul 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151543 decided 7 Jul 2015 Active
  • FDA GUDID UDI-DI 00815634020894 listed 23 Apr 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151543
  2. Listed FDA GUDID 00815634020894

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Biocomposites
Generic name
Bone graft delivery kit
Model / reference
990-001
Primary DI / UDI-DI
00815634020894
510(k) Number
FDA product code
FMF
GMDN term
Bone graft delivery kit
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone graft delivery kit

Cleared under the same submission (K151543)

and 8 more cleared under K151543

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from Micromedics, Inc.

See all devices from Micromedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)