The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Short Lateral Superior Clavicle Plate, Left And Right Model 3017-000 (left) And 3018-000 (right); 6 Hole Medium Midshaft.
| Device ID | K122623 |
| 510k Number | K122623 |
| Device Name: | SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT |
| Classification | Plate, Fixation, Bone |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance, CA 90501 |
| Contact | Allyson Parks |
| Correspondent | Allyson Parks 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-28 |
| Decision Date | 2012-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665013801 | K122623 | 000 |
| 00848665006209 | K122623 | 000 |
| 00848665006216 | K122623 | 000 |
| 00848665006223 | K122623 | 000 |
| 00848665006230 | K122623 | 000 |
| 00848665006247 | K122623 | 000 |
| 00848665006254 | K122623 | 000 |
| 00848665006261 | K122623 | 000 |
| 00848665006278 | K122623 | 000 |
| 00848665006285 | K122623 | 000 |
| 00848665006292 | K122623 | 000 |
| 00848665006308 | K122623 | 000 |
| 00848665013757 | K122623 | 000 |
| 00848665013764 | K122623 | 000 |
| 00848665013771 | K122623 | 000 |
| 00848665013788 | K122623 | 000 |
| 00848665013795 | K122623 | 000 |
| 00848665006193 | K122623 | 000 |