SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
FDA 510(k) clearance K063181 · decided 2007-01-05
Clearance details
- K-number
- K063181
- Device name
- SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2006-10-19
- Decision date
- 2007-01-05
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- NEI
- Device class
- 2
- Regulation number
- 872.4770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STRYKER TEMPORARY CONDYLAR PROSTHESIS (K133285) | Stryker | 2014-04-09 |
| MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM (K081747) | Synthes (Usa) | 2008-09-05 |
| OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM (K031701) | Osteomed LP | 2004-07-08 |
| ADD-ON CONDYLE (K002790) | Walter Lorenz Surgical, Inc. | 2001-08-06 |
| KLS-MARTIN TEMPORARY CONDYLAR IMPLANT (K990667) | KLS-Martin L.P. | 2001-07-27 |
| SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD (K990637) | Synthes (Usa) | 1999-10-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |