Adg Bone Plug

FDA 510(k) K902615 · American Design Group, Inc.

Substantially Equivalent

510(k) numberK902615

Submission

Device name
Adg Bone Plug
Applicant
American Design Group, Inc.
Concord, CA, US
Received
June 13, 1990
Decision date
September 11, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LZN – Cement Obturator
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code LZN

510(k)DeviceApplicantDecision
K220838Artisan Bone Plug, Universal Cement RestrictorLZN · Traditional Howmedica Osteonics, Dba Stryker Orthopaedics05/20/2022SE
K061824Tornier Cement RestrictorLZN · Traditional Tornier09/14/2006SE
K032685Cemstop Cement RestrictorLZN · Traditional Teknimed, S.A.11/26/2003SE
K023680Biobuck Cement RestrictorLZN · Special Smith & Nephew, Inc.11/19/2002SE
K011943Impro Vise Absorbable Cement Flow RestrictorLZN · Traditional Kensey Nash Corp.09/19/2001SE
K010840SynplugLZN · Special Isotis NV04/20/2001SE
K993841Cemstop Cement RestrictorLZN · Traditional Encore Orthopedics, Inc.05/04/2000SE
K000587Shuttle StopLZN · Traditional Isotis NV05/04/2000SE
K992462Osteonics Universal Distal Cement PlugLZN · Traditional Howmedica Osteonics Corp.08/13/1999SE
K972411Link Cement PlugLZN · Traditional Turnkey Intergration USA, Inc.08/29/1997SE

More from Turnkey Intergration USA, Inc.

510(k)DeviceDecision
K911717Adg Intramedullary Bone Plug - VentedLZN · Traditional 09/04/1991SE
K890722Adg Bone Biopsy SystemGDM · Traditional 09/21/1989SE

Questions and answers

When was Adg Bone Plug cleared by the FDA?

Adg Bone Plug (K902615) received a 510(k) decision of Substantially Equivalent on September 11, 1990, 90 days after the submission was received.

What is the product code of K902615?

The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.