The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Pediatric Lcp Hip Plate System Modifications.
| Device ID | K072095 |
| 510k Number | K072095 |
| Device Name: | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS |
| Classification | Nail, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Jill Sherman |
| Correspondent | Jill Sherman 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 | 2007-07-31 |
| Decision Date | 2007-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679021083430 | K072095 | 000 |
| H679021083010 | K072095 | 000 |
| H679021083030 | K072095 | 000 |
| H679021083160 | K072095 | 000 |
| H679021083260 | K072095 | 000 |
| H679021083300 | K072095 | 000 |
| H679021083310 | K072095 | 000 |
| H679021083320 | K072095 | 000 |
| H679021083330 | K072095 | 000 |
| H679021083400 | K072095 | 000 |
| H679021083410 | K072095 | 000 |
| H679021083420 | K072095 | 000 |
| H679021083000 | K072095 | 000 |