The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Epoca Shoulder Prosthesis System.
| Device ID | K072578 |
| 510k Number | K072578 |
| Device Name: | SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri Musgnung SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | HSD |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-13 |
| Decision Date | 2007-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6795213540 | K072578 | 000 |
| H679553710120 | K072578 | 000 |
| H679553712130 | K072578 | 000 |
| H679553714130 | K072578 | 000 |
| H67955376110 | K072578 | 000 |
| H67955378120 | K072578 | 000 |
| H679562410120 | K072578 | 000 |
| H67956241016L0 | K072578 | 000 |
| H67956241020XL0 | K072578 | 000 |
| H67954132050 | K072578 | 000 |
| H679533158220 | K072578 | 000 |
| H679533142150 | K072578 | 000 |
| H679533144160 | K072578 | 000 |
| H679533146170 | K072578 | 000 |
| H679533148180 | K072578 | 000 |
| H679533150180 | K072578 | 000 |
| H679533152190 | K072578 | 000 |
| H679533154200 | K072578 | 000 |
| H679533156210 | K072578 | 000 |
| H679562412130 | K072578 | 000 |
| H67956241217L0 | K072578 | 000 |
| H6795213560 | K072578 | 000 |
| H6795213580 | K072578 | 000 |
| H6795213420 | K072578 | 000 |
| H6795213440 | K072578 | 000 |
| H6795213460 | K072578 | 000 |
| H6795213480 | K072578 | 000 |
| H6795213500 | K072578 | 000 |
| H6795213520 | K072578 | 000 |
| H6795624820XL0 | K072578 | 000 |
| H6795624816L0 | K072578 | 000 |
| H67956241221XL0 | K072578 | 000 |
| H679562414130 | K072578 | 000 |
| H67956241417L0 | K072578 | 000 |
| H67956241421XL0 | K072578 | 000 |
| H67956246110 | K072578 | 000 |
| H6795624615L0 | K072578 | 000 |
| H6795624619XL0 | K072578 | 000 |
| H67956248120 | K072578 | 000 |
| H679533140150 | K072578 | 000 |