The following data is part of a premarket notification filed by Dunamis Llc with the FDA for Dunamis Interference Screw.
| Device ID | K151220 |
| 510k Number | K151220 |
| Device Name: | Dunamis Interference Screw |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Dunamis LLC 693 Sherling Lake Rd. Greenville, AL 36037 |
| Contact | Prithvi Raj Chavan |
| Correspondent | Robert O. Dean LEXAMED 705 FRONT ST. Toledo, OH 43605 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-07 |
| Decision Date | 2015-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854629006130 | K151220 | 000 |
| 00854629006123 | K151220 | 000 |
| 00854629006116 | K151220 | 000 |
| 00854629006109 | K151220 | 000 |