The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Es Trochanteric Nail, Left And Right, 10mm.
Device ID | K103533 |
510k Number | K103533 |
Device Name: | ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance, CA 90501 |
Contact | Julie Glendrange |
Correspondent | Julie Glendrange ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance, CA 90501 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-01 |
Decision Date | 2011-01-19 |
Summary: | summary |