The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5mm Lcp Periarticular Proximal Humerus Plates.
| Device ID | K082625 |
| 510k Number | K082625 |
| Device Name: | SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger 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 | 2008-09-09 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679041230200 | K082625 | 000 |
| H679041230290 | K082625 | 000 |
| H67904123029S0 | K082625 | 000 |
| H679041230300 | K082625 | 000 |
| H67904123030S0 | K082625 | 000 |
| H679041230310 | K082625 | 000 |
| H67904123031S0 | K082625 | 000 |
| H67904123032S0 | K082625 | 000 |
| H67904123033S0 | K082625 | 000 |
| H679041230400 | K082625 | 000 |
| H67904123040S0 | K082625 | 000 |
| H679041230410 | K082625 | 000 |
| H67904123041S0 | K082625 | 000 |
| H679041230420 | K082625 | 000 |
| H67904123042S0 | K082625 | 000 |
| H679041230430 | K082625 | 000 |
| H67904123028S0 | K082625 | 000 |
| H679041230280 | K082625 | 000 |
| H67904123020S0 | K082625 | 000 |
| H679041230210 | K082625 | 000 |
| H67904123021S0 | K082625 | 000 |
| H679041230220 | K082625 | 000 |
| H67904123022S0 | K082625 | 000 |
| H679041230230 | K082625 | 000 |
| H67904123023S0 | K082625 | 000 |
| H679041230240 | K082625 | 000 |
| H67904123024S0 | K082625 | 000 |
| H679041230250 | K082625 | 000 |
| H67904123025S0 | K082625 | 000 |
| H679041230260 | K082625 | 000 |
| H67904123026S0 | K082625 | 000 |
| H679041230270 | K082625 | 000 |
| H67904123027S0 | K082625 | 000 |
| H67904123043S0 | K082625 | 000 |
| H679021230200 | K082625 | 000 |
| H679021230290 | K082625 | 000 |
| H67902123029S0 | K082625 | 000 |
| H679021230300 | K082625 | 000 |
| H67902123030S0 | K082625 | 000 |
| H679021230310 | K082625 | 000 |
| H67902123031S0 | K082625 | 000 |
| H67902123032S0 | K082625 | 000 |
| H67902123033S0 | K082625 | 000 |
| H679021230400 | K082625 | 000 |
| H67902123040S0 | K082625 | 000 |
| H679021230410 | K082625 | 000 |
| H67902123041S0 | K082625 | 000 |
| H679021230420 | K082625 | 000 |
| H67902123042S0 | K082625 | 000 |
| H679021230430 | K082625 | 000 |
| H67902123028S0 | K082625 | 000 |
| H679021230280 | K082625 | 000 |
| H67902123020S0 | K082625 | 000 |
| H679021230210 | K082625 | 000 |
| H67902123021S0 | K082625 | 000 |
| H679021230220 | K082625 | 000 |
| H67902123022S0 | K082625 | 000 |
| H679021230230 | K082625 | 000 |
| H67902123023S0 | K082625 | 000 |
| H679021230240 | K082625 | 000 |
| H67902123024S0 | K082625 | 000 |
| H679021230250 | K082625 | 000 |
| H67902123025S0 | K082625 | 000 |
| H679021230260 | K082625 | 000 |
| H67902123026S0 | K082625 | 000 |
| H679021230270 | K082625 | 000 |
| H67902123027S0 | K082625 | 000 |
| H67902123043S0 | K082625 | 000 |