The following data is part of a premarket notification filed by Shoulder Options, Inc. with the FDA for Icuff Repair Plate, Right; Cuff Repair Plate. Left; Anchor Bolt, 10mm Through 50mm.
Device ID | K102539 |
510k Number | K102539 |
Device Name: | ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | SHOULDER OPTIONS, INC. 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw, NC 28173 |
Contact | John Kapitan |
Correspondent | John Kapitan SHOULDER OPTIONS, INC. 100 E. SOUTH MAIN ST. P.O. BOX 1458 Waxhaw, NC 28173 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-03 |
Decision Date | 2011-02-24 |
Summary: | summary |