The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Pediatric Lcp Hip Plate System.
| Device ID | K062872 |
| 510k Number | K062872 |
| Device Name: | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM |
| Classification | Nail, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-26 |
| Decision Date | 2007-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902108325S0 | K062872 | 000 |
| H67902108310S0 | K062872 | 000 |
| H679021083110 | K062872 | 000 |
| H67902108311S0 | K062872 | 000 |
| H679021083130 | K062872 | 000 |
| H67902108313S0 | K062872 | 000 |
| H679021083150 | K062872 | 000 |
| H67902108315S0 | K062872 | 000 |
| H679021083200 | K062872 | 000 |
| H67902108320S0 | K062872 | 000 |
| H679021083210 | K062872 | 000 |
| H67902108321S0 | K062872 | 000 |
| H679021083230 | K062872 | 000 |
| H67902108323S0 | K062872 | 000 |
| H679021083250 | K062872 | 000 |
| H679021083100 | K062872 | 000 |