Osteonics Universal Distal Cement Plug
FDA 510(k) K992462 · Howmedica Osteonics Corp.
510(k) numberK992462
Submission
- Device name
- Osteonics Universal Distal Cement Plug
- Applicant
- Howmedica Osteonics Corp.
Allendale, NJ, US - Received
- July 23, 1999
- Decision date
- August 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement RestrictorLZN · Traditional | Howmedica Osteonics, Dba Stryker Orthopaedics | 05/20/2022SE |
| K061824 | Tornier Cement RestrictorLZN · Traditional | Tornier | 09/14/2006SE |
| K032685 | Cemstop Cement RestrictorLZN · Traditional | Teknimed, S.A. | 11/26/2003SE |
| K023680 | Biobuck Cement RestrictorLZN · Special | Smith & Nephew, Inc. | 11/19/2002SE |
| K011943 | Impro Vise Absorbable Cement Flow RestrictorLZN · Traditional | Kensey Nash Corp. | 09/19/2001SE |
| K010840 | SynplugLZN · Special | Isotis NV | 04/20/2001SE |
| K993841 | Cemstop Cement RestrictorLZN · Traditional | Encore Orthopedics, Inc. | 05/04/2000SE |
| K000587 | Shuttle StopLZN · Traditional | Isotis NV | 05/04/2000SE |
| K972411 | Link Cement PlugLZN · Traditional | Turnkey Intergration USA, Inc. | 08/29/1997SE |
| K970779 | Osteonics Tibial Tray Screw Hole PlugsLZN · Traditional | Osteonics Corp. | 05/09/1997SE |
More from Osteonics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit CupJDI · Traditional | 08/13/2020SE |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…MBH · Traditional | 05/13/2020SE |
| K130895 | Reunion Rsa Shoulder SystemPHX · Traditional | 12/27/2013SE |
| K123604 | Abg III Monolithic Hip StemMAY · Traditional | 08/16/2013SE |
| K122015 | Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…KRO · Traditional | 02/22/2013SE |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…JWH · Traditional | 02/14/2013SE |
| K122853 | Novel Fit and Fill StemMEH · Traditional | 02/01/2013SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | 11/01/2012SE |
| K121308 | Hip SystemsLPH · Traditional | 07/30/2012SE |
| K120578 | Accolade II Hip StemJDI · Special | 03/29/2012SE |
Questions and answers
When was Osteonics Universal Distal Cement Plug cleared by the FDA?
Osteonics Universal Distal Cement Plug (K992462) received a 510(k) decision of Substantially Equivalent on August 13, 1999, 21 days after the submission was received.
What is the product code of K992462?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.