Osteonics Tibial Tray Screw Hole Plugs
FDA 510(k) K970779 · Osteonics Corp.
510(k) numberK970779
Submission
- Device name
- Osteonics Tibial Tray Screw Hole Plugs
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- March 4, 1997
- Decision date
- May 9, 1997
- 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 |
| K992462 | Osteonics Universal Distal Cement PlugLZN · Traditional | Howmedica Osteonics Corp. | 08/13/1999SE |
| K972411 | Link Cement PlugLZN · Traditional | Turnkey Intergration USA, Inc. | 08/29/1997SE |
More from Turnkey Intergration USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983657 | Osteonics Series 7000 Ad Tibial TrayHRY · Traditional | 04/06/2000SE |
| K980070 | Osteonics Ha-Coated DevicesMEH · Traditional | 07/23/1999SE |
| K984375 | Osteonics Spinal System - Sacral Offset Connector AssemblyKWP · Traditional | 04/30/1999SE |
| K982798 | Osteonics Anterior Cervical Compression Plating SystemKWQ · Traditional | 03/25/1999SE |
| K984585 | Osteonics +10 Unipolar Adaptor SleeveKWL · Traditional | 02/24/1999SE |
| K990203 | Osteonics Primary Secur-Fit Plus Hip StemsMEH · Special | 02/18/1999SE |
| K990158 | Osteonics Combination Screw Ring/BlockerMNI · Special | 02/01/1999SE |
| K984302 | Osteonics Spinal System Cylindrical Bone ScrewsMNH · Special | 12/18/1998SE |
| K984353 | Osteo 9MM Ic Tibial NailHSB · Special | 12/16/1998SE |
| K983502 | Osteonics Secur-Fit Ad Generation II Acetabular Component SystemLPH · Traditional | 12/16/1998SE |
Questions and answers
When was Osteonics Tibial Tray Screw Hole Plugs cleared by the FDA?
Osteonics Tibial Tray Screw Hole Plugs (K970779) received a 510(k) decision of Substantially Equivalent on May 9, 1997, 66 days after the submission was received.
What is the product code of K970779?
The FDA product code is LZN – Cement Obturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.