The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Suprapatellar Insertion Instruments.
| Device ID | K111667 |
| 510k Number | K111667 |
| Device Name: | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS |
| Classification | Nail, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Christopher Hack |
| Correspondent | Christopher Hack SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-14 |
| Decision Date | 2011-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679030104400 | K111667 | 000 |
| H679030104350 | K111667 | 000 |
| H679030104360 | K111667 | 000 |
| H67903010437S0 | K111667 | 000 |
| H67903010438S0 | K111667 | 000 |
| H679030104410 | K111667 | 000 |
| H679030104420 | K111667 | 000 |
| H679030104550 | K111667 | 000 |
| H679030104560 | K111667 | 000 |
| H679030104330 | K111667 | 000 |
| H679030104340 | K111667 | 000 |
| H679030104300 | K111667 | 000 |