The following data is part of a premarket notification filed by Dunamis Llc with the FDA for Dunamis Suture Anchor Peek 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm.
| Device ID | K160996 |
| 510k Number | K160996 |
| Device Name: | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Dunamis LLC 693 Sherling Lake Rd Apt 122 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 | 2016-04-08 |
| Decision Date | 2016-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085462900653 | K160996 | 000 |
| 00854629006246 | K160996 | 000 |
| 00854629006222 | K160996 | 000 |
| 10854629006205 | K160996 | 000 |
| 00854629006192 | K160996 | 000 |
| 10854629006175 | K160996 | 000 |
| 10854629006168 | K160996 | 000 |
| 00854629006154 | K160996 | 000 |
| 00854629006536 | K160996 | 000 |
| 10854629006779 | K160996 | 000 |
| 00854629006260 | K160996 | 000 |
| 00854629006284 | K160996 | 000 |
| 00854629006642 | K160996 | 000 |
| 10854629006625 | K160996 | 000 |
| 00854629006611 | K160996 | 000 |
| 10854629006595 | K160996 | 000 |
| 00854629006581 | K160996 | 000 |
| 00854629006550 | K160996 | 000 |
| 00854629006529 | K160996 | 000 |
| 00854629006512 | K160996 | 000 |
| 10854629006298 | K160996 | 000 |
| 00854629006321 | K160996 | 000 |