The following data is part of a premarket notification filed by Austin & Associates, Inc./telos Medical Equipment with the FDA for Memodyn Staple.
| Device ID | K161587 |
| 510k Number | K161587 |
| Device Name: | Memodyn Staple |
| Classification | Staple, Fixation, Bone |
| Applicant | AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT 212 COPPERWOOD COURT Millersville, MD 21108 |
| Contact | Al Austin |
| Correspondent | Al Austin Austin And Associates, Inc./Telos Medical Equipment 212 Copperwood Court Millersville, MD 21108 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-08 |
| Decision Date | 2017-02-01 |
| Summary: | summary |