The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Dynamic Compression Shape Memory Alloy (sma) Staple System.
| Device ID | K012081 |
| 510k Number | K012081 |
| Device Name: | DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-03 |
| Decision Date | 2001-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902671838 | K012081 | 000 |
| 00721902671814 | K012081 | 000 |
| 00721902671784 | K012081 | 000 |
| 00721902662645 | K012081 | 000 |
| 00885074423890 | K012081 | 000 |
| 00885074051444 | K012081 | 000 |
| 00885074051437 | K012081 | 000 |