The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Speedlock Knotless Fixation Device; 3.0mm Drill; Sharp Tipped Obturator; Low Profile Drill Guidde.
Device ID | K111044 |
510k Number | K111044 |
Device Name: | SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | ARTHROCARE CORPORATION 15285 ALTON PARKWAY SUITE 209 Irvine, CA 92618 |
Contact | Laura Kasperowicz |
Correspondent | Laura Kasperowicz ARTHROCARE CORPORATION 15285 ALTON PARKWAY SUITE 209 Irvine, CA 92618 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-15 |
Decision Date | 2011-08-09 |
Summary: | summary |