The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5mm Spring Plate.
| Device ID | K061973 |
| 510k Number | K061973 |
| Device Name: | SYNTHES 3.5MM SPRING PLATE |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-12 |
| Decision Date | 2006-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902100303S0 | K061973 | 000 |
| H679021003030 | K061973 | 000 |
| H67902100302S0 | K061973 | 000 |
| H679021003020 | K061973 | 000 |
| H67902100301S0 | K061973 | 000 |
| H679021003010 | K061973 | 000 |