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 |