The following data is part of a premarket notification filed by Synthes Spine with the FDA for Modification To Synthes Matrix System.
Device ID | K100952 |
510k Number | K100952 |
Device Name: | MODIFICATION TO SYNTHES MATRIX SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Contact | Jason Lipman |
Correspondent | Jason Lipman SYNTHES SPINE 1302 WRIGHTS LANE 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-06 |
Decision Date | 2010-08-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H981SD096331970 | K100952 | 000 |
H981SD096331950 | K100952 | 000 |