The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Mirs.
Device ID | K113044 |
510k Number | K113044 |
Device Name: | SYNTHES MIRS |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
Contact | Heather Guerin |
Correspondent | Heather Guerin SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-12 |
Decision Date | 2011-12-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H981046315020 | K113044 | 000 |
H981046517100 | K113044 | 000 |
H981046517200 | K113044 | 000 |
H981046517300 | K113044 | 000 |
H981046517400 | K113044 | 000 |
H981046517500 | K113044 | 000 |
H981046516100 | K113044 | 000 |
H981046516200 | K113044 | 000 |
H981046516300 | K113044 | 000 |
H981046516400 | K113044 | 000 |
H981046516500 | K113044 | 000 |
H981046516600 | K113044 | 000 |
H981046516700 | K113044 | 000 |
H981046516800 | K113044 | 000 |
H981046516900 | K113044 | 000 |
H981046315000 | K113044 | 000 |
H981046517000 | K113044 | 000 |