The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Lateral Superior Clavicle Plate, Left And Right; Midshaft Superior Clavicle Plate, Left And Right; Anterior Clavicle Pla.
| Device ID | K103513 |
| 510k Number | K103513 |
| Device Name: | LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-30 |
| Decision Date | 2011-10-24 |
| Summary: | summary |