The following data is part of a premarket notification filed by Synthes Usa with the FDA for 4.5mm Va-lcp Curved Condylar Plate System.
| Device ID | K110354 |
| 510k Number | K110354 |
| Device Name: | 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM |
| Classification | Condylar Plate Fixation Implant |
| Applicant | SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Thomas N Shea |
| Correspondent | Thomas N Shea SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | JDP |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-07 |
| Decision Date | 2011-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902231008S0 | K110354 | 000 |
| H679022316400 | K110354 | 000 |
| H679022316450 | K110354 | 000 |
| H679022316500 | K110354 | 000 |
| H679022316550 | K110354 | 000 |
| H679022316600 | K110354 | 000 |
| H679022316650 | K110354 | 000 |
| H679022316700 | K110354 | 000 |
| H679022316750 | K110354 | 000 |
| H679022316800 | K110354 | 000 |
| H679022316850 | K110354 | 000 |
| H679022316900 | K110354 | 000 |
| H67902231695S0 | K110354 | 000 |
| H67902231700S0 | K110354 | 000 |
| H67902231705S0 | K110354 | 000 |
| H67902231710S0 | K110354 | 000 |
| H679032310020 | K110354 | 000 |
| H679022316350 | K110354 | 000 |
| H679022316300 | K110354 | 000 |
| H679022310100 | K110354 | 000 |
| H67902231010S0 | K110354 | 000 |
| H679022310120 | K110354 | 000 |
| H67902231012S0 | K110354 | 000 |
| H679022310140 | K110354 | 000 |
| H67902231014S0 | K110354 | 000 |
| H679022310160 | K110354 | 000 |
| H67902231016S0 | K110354 | 000 |
| H679022310180 | K110354 | 000 |
| H67902231018S0 | K110354 | 000 |
| H67902231295S0 | K110354 | 000 |
| H67902231300S0 | K110354 | 000 |
| H67902231305S0 | K110354 | 000 |
| H67902231310S0 | K110354 | 000 |
| H679022316200 | K110354 | 000 |
| H679022316250 | K110354 | 000 |
| H679032310030 | K110354 | 000 |
| H679032310040 | K110354 | 000 |
| H679032310050 | K110354 | 000 |
| H67904124413S0 | K110354 | 000 |
| H679041244140 | K110354 | 000 |
| H67904124414S0 | K110354 | 000 |
| H679041244150 | K110354 | 000 |
| H67904124415S0 | K110354 | 000 |
| H679041244160 | K110354 | 000 |
| H67904124416S0 | K110354 | 000 |
| H679041244170 | K110354 | 000 |
| H67904124417S0 | K110354 | 000 |
| H679041244180 | K110354 | 000 |
| H67904124418S0 | K110354 | 000 |
| H679041244190 | K110354 | 000 |
| H67904124419S0 | K110354 | 000 |
| H67904124420S0 | K110354 | 000 |
| H67904124421S0 | K110354 | 000 |
| H67904124422S0 | K110354 | 000 |
| H679041244130 | K110354 | 000 |
| H67904124412S0 | K110354 | 000 |
| H679032310060 | K110354 | 000 |
| H679032310070 | K110354 | 000 |
| H679032310010 | K110354 | 000 |
| H679041244060 | K110354 | 000 |
| H67904124406S0 | K110354 | 000 |
| H679041244070 | K110354 | 000 |
| H67904124407S0 | K110354 | 000 |
| H679041244080 | K110354 | 000 |
| H67904124408S0 | K110354 | 000 |
| H679041244090 | K110354 | 000 |
| H67904124409S0 | K110354 | 000 |
| H679041244100 | K110354 | 000 |
| H67904124410S0 | K110354 | 000 |
| H679041244110 | K110354 | 000 |
| H67904124411S0 | K110354 | 000 |
| H679041244120 | K110354 | 000 |
| H67904124423S0 | K110354 | 000 |