The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Aesculap Resorbable Pin, Model Fr735.
| Device ID | K070178 |
| 510k Number | K070178 |
| Device Name: | AESCULAP RESORBABLE PIN, MODEL FR735 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-19 |
| Decision Date | 2007-04-30 |
| Summary: | summary |