The following data is part of a premarket notification filed by Synthes with the FDA for Synthecel Dura Replacement Devices.
Device ID | K113071 |
510k Number | K113071 |
Device Name: | SYNTHECEL DURA REPLACEMENT DEVICES |
Classification | Dura Substitute |
Applicant | SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
Contact | Andrea M Tasker |
Correspondent | Andrea M Tasker SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
Product Code | GXQ |
CFR Regulation Number | 882.5910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-17 |
Decision Date | 2012-01-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H980SC40012001S0 | K113071 | 000 |
H980SC40005601S0 | K113071 | 000 |
H980SC40002501S0 | K113071 | 000 |
H980SC40001901S0 | K113071 | 000 |
H980SC40000601S0 | K113071 | 000 |