The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Clavicle Hook Plates.
| Device ID | K061753 |
| 510k Number | K061753 |
| Device Name: | SYNTHES (USA) CLAVICLE HOOK PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Deborah Jackson |
| Correspondent | Deborah Jackson SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-21 |
| Decision Date | 2006-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679241107S0 | K061753 | 000 |
| H679441087S0 | K061753 | 000 |
| H679441094S0 | K061753 | 000 |
| H679441095S0 | K061753 | 000 |
| H679441096S0 | K061753 | 000 |
| H679441097S0 | K061753 | 000 |
| H679441104S0 | K061753 | 000 |
| H679441105S0 | K061753 | 000 |
| H679441106S0 | K061753 | 000 |
| H679441086S0 | K061753 | 000 |
| H679441085S0 | K061753 | 000 |
| H679441073S0 | K061753 | 000 |
| H679441074S0 | K061753 | 000 |
| H679441075S0 | K061753 | 000 |
| H679441076S0 | K061753 | 000 |
| H679441077S0 | K061753 | 000 |
| H679441082S0 | K061753 | 000 |
| H679441083S0 | K061753 | 000 |
| H679441084S0 | K061753 | 000 |
| H679441107S0 | K061753 | 000 |
| H679241072S0 | K061753 | 000 |
| H679241087S0 | K061753 | 000 |
| H679241094S0 | K061753 | 000 |
| H679241095S0 | K061753 | 000 |
| H679241096S0 | K061753 | 000 |
| H679241097S0 | K061753 | 000 |
| H679241104S0 | K061753 | 000 |
| H679241105S0 | K061753 | 000 |
| H679241106S0 | K061753 | 000 |
| H679241086S0 | K061753 | 000 |
| H679241085S0 | K061753 | 000 |
| H679241073S0 | K061753 | 000 |
| H679241074S0 | K061753 | 000 |
| H679241075S0 | K061753 | 000 |
| H679241076S0 | K061753 | 000 |
| H679241077S0 | K061753 | 000 |
| H679241082S0 | K061753 | 000 |
| H679241083S0 | K061753 | 000 |
| H679241084S0 | K061753 | 000 |
| H679441072S0 | K061753 | 000 |