The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Multifix P Knotless Fixation Device.
Device ID | K120096 |
510k Number | K120096 |
Device Name: | MULTIFIX P KNOTLESS FIXATION DEVICE |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
Contact | Cheryl Frederick |
Correspondent | Cheryl Frederick ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-12 |
Decision Date | 2012-03-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817470003390 | K120096 | 000 |
00817470003383 | K120096 | 000 |
00817470003369 | K120096 | 000 |
00817470003291 | K120096 | 000 |
00817470003284 | K120096 | 000 |
00817470003178 | K120096 | 000 |