Stryker Temporary Condylar Prosthesis
FDA 510(k) K133285 · Stryker
510(k) numberK133285
Submission
- Device name
- Stryker Temporary Condylar Prosthesis
- Applicant
- Stryker
Portage, MI, US - Received
- October 25, 2013
- Decision date
- April 9, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081747 | Modification to Synthes (USA) Condylar Head Add-On SystemNEI · Traditional | Synthes (Usa) | 09/05/2008SE |
| K063181 | Synthes (USA) Condylar Head Add-On SystemNEI · Traditional | Synthes (Usa) | 01/05/2007SE |
| K031701 | Osteomed Temporary Condylar Attachment SystemNEI · Traditional | Osteomed LP | 07/08/2004SE |
| K002790 | Add-On CondyleNEI · Traditional | Walter Lorenz Surgical, Inc. | 08/06/2001SE |
| K990667 | Kls-Martin Temporary Condylar ImplantNEI · Traditional | KLS-Martin L.P. | 07/27/2001SE |
| K990637 | Synthes Locking Reconstruction Plate (LRP) with Condylar HeadNEI · Traditional | Synthes (Usa) | 10/22/1999SE |
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| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
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Questions and answers
When was Stryker Temporary Condylar Prosthesis cleared by the FDA?
Stryker Temporary Condylar Prosthesis (K133285) received a 510(k) decision of Substantially Equivalent on April 9, 2014, 166 days after the submission was received.
What is the product code of K133285?
The FDA product code is NEI – Prosthesis, Condyle, Mandibular, Temporary, a Class II (moderate risk) device regulated under 21 CFR 872.4770.