The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Locking Condylar Plate (lcp) System.
| Device ID | K000066 |
| 510k Number | K000066 |
| Device Name: | SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HRS |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-10 |
| Decision Date | 2000-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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