The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5 Mm Lcp Distal Tibia T Plates.
| Device ID | K080522 |
| 510k Number | K080522 |
| Device Name: | SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung 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 | 2008-02-26 |
| Decision Date | 2008-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902112216S0 | K080522 | 000 |
| H67902112203S0 | K080522 | 000 |
| H679021122050 | K080522 | 000 |
| H67902112205S0 | K080522 | 000 |
| H679021122080 | K080522 | 000 |
| H67902112208S0 | K080522 | 000 |
| H679021122120 | K080522 | 000 |
| H67902112212S0 | K080522 | 000 |
| H679021122160 | K080522 | 000 |
| H679021122030 | K080522 | 000 |