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StaGraft DBM Plus 92-2005

by Biomet Orthopedics, Inc.

StaGraft DBM Plus 92-2005 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K082793 on 2 Apr 2009 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304684874), active as of 23 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 23 Oct 2026

Documents

510(k) K082793

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 Number00880304684874 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082793 Date2 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082793 decided 2 Apr 2009 Active
  • FDA GUDID UDI-DI 00880304684874 listed 24 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082793
  2. Listed FDA GUDID 00880304684874

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
StaGraft DBM Plus
Generic name
Human-derived demineralized bone matrix implant
Model / Ref / Catalog
92-2005
Primary DI / UDI-DI
00880304684874
510(k) Number
FDA product code
MQV, MBP, GXP
GMDN term
Human-derived demineralized bone matrix implant
Device class
Class II
Regulation number
888.3045, 882.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone matrix implant, human-derived

Cleared under the same submission (K082793)

and 8 more cleared under K082793

Similar devices

Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).

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)