Osteonics Unix Unicompartmental
FDA 510(k) K923011 · Osteonics Corp.
510(k) numberK923011
Submission
- Device name
- Osteonics Unix Unicompartmental
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- June 22, 1992
- Decision date
- November 30, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3530
- Specialty
- Orthopedic
- Implant
- Yes
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| K152631 | MPO Total Knee Systems MR LabelingHRY · Traditional | Microport Orthopedics, Inc. | 03/23/2016SE |
| K150410 | Restoris Porous Partial Knee SystemHRY · Special | Mako Surgical Corporation | 03/20/2015SE |
| K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)HRY · Traditional | Biomet UK, Ltd. | 03/28/2014SE |
| K131167 | UnivationHRY · Traditional | Aesculap Implant Systems, LLC | 10/17/2013SE |
| K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford…HRY · Traditional | Biomet Manufacturing Corp | 10/22/2012SE |
| K110415 | Signature Planner / Signature GuidesHRY · Traditional | Materialise NV | 05/16/2011SE |
| K100973 | Evolution Unicondylar Knee SystemHRY · Traditional | Wrightmedicaltechnologyinc | 08/10/2010SE |
| K082567 | Stryker Compartmental Knee System Line ExtensionHRY · Special | Howmedica Osteonics Corp. | 10/03/2008SE |
More from Howmedica Osteonics Corp.
| 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 Unix Unicompartmental cleared by the FDA?
Osteonics Unix Unicompartmental (K923011) received a 510(k) decision of Substantially Equivalent on November 30, 1993, 526 days after the submission was received.
What is the product code of K923011?
The FDA product code is HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3530.