The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Atlas Humeral Plating System.
| Device ID | K110700 |
| 510k Number | K110700 |
| Device Name: | ASCENSION ATLAS HUMERAL PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Contact | Susan Walton |
| Correspondent | Susan Walton ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-12-06 |
| Summary: | summary |