Kls-Martin Temporary Condylar Implant
FDA 510(k) K990667 · KLS-Martin L.P.
510(k) numberK990667
Submission
- Device name
- Kls-Martin Temporary Condylar Implant
- Applicant
- KLS-Martin L.P.
New Port Riche, FL, US - Received
- March 2, 1999
- Decision date
- July 27, 2001
- 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 |
|---|---|---|---|
| K133285 | Stryker Temporary Condylar ProsthesisNEI · Traditional | Stryker | 04/09/2014SE |
| 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 |
| K990637 | Synthes Locking Reconstruction Plate (LRP) with Condylar HeadNEI · Traditional | Synthes (Usa) | 10/22/1999SE |
More from Synthes (Usa)
| 510(k) | Device | Decision |
|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | 08/17/2026SE |
| K254162 | KLS Martin Ixos SystemHRS · Traditional | 02/20/2026SE |
| K253660 | KLS Martin Pure Pectus SystemHRS · Traditional | 02/20/2026SE |
| K250988 | KLS Martin Pure Pectus SystemHRS · Traditional | 12/11/2025SE |
| K250865 | KLS Martin IPS Forearm SystemHRS · Traditional | 11/14/2025SE |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | 11/10/2025SE |
| K250620 | KLS Martin Ixos SystemHRS · Traditional | 08/15/2025SE |
| K233721 | KLS Martin Drill-Free MMF ScrewDZL · Traditional | 09/17/2024SE |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional | 08/16/2024SE |
| K241018 | KLS Martin Orthopedic Implants - MR ConditionalHRS · Traditional | 07/12/2024SE |
Questions and answers
When was Kls-Martin Temporary Condylar Implant cleared by the FDA?
Kls-Martin Temporary Condylar Implant (K990667) received a 510(k) decision of Substantially Equivalent on July 27, 2001, 878 days after the submission was received.
What is the product code of K990667?
The FDA product code is NEI – Prosthesis, Condyle, Mandibular, Temporary, a Class II (moderate risk) device regulated under 21 CFR 872.4770.