The following data is part of a premarket notification filed by Medshape, Inc. with the FDA for Dynafuse Fixation System.
| Device ID | K203595 |
| 510k Number | K203595 |
| Device Name: | DynaFuse Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | MedShape, Inc. 1575 Northside Drive NW, Suite 440 Atlanta, GA 30318 |
| Contact | Ryan O'flaherty |
| Correspondent | Ryan O'flaherty MedShape, Inc. 1575 Northside Drive NW, Suite 440 Atlanta, GA 30318 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-09 |
| Decision Date | 2022-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M97032000170500 | K203595 | 000 |
| M97032000170900 | K203595 | 000 |
| M97032000170850 | K203595 | 000 |
| M97032000170800 | K203595 | 000 |
| M97032000170750 | K203595 | 000 |
| M97032000170700 | K203595 | 000 |
| M97032000170650 | K203595 | 000 |
| M97032000170600 | K203595 | 000 |
| M97032000170550 | K203595 | 000 |
| M97032000171100 | K203595 | 000 |
| M97031001200010 | K203595 | 000 |
| M97031000900010 | K203595 | 000 |
| M97031000700010 | K203595 | 000 |
| M97031000400010 | K203595 | 000 |
| M97031000100050 | K203595 | 000 |
| M97032000170950 | K203595 | 000 |
| M97032000171000 | K203595 | 000 |
| M97032000071100 | K203595 | 000 |
| M97032000071050 | K203595 | 000 |
| M97032000071000 | K203595 | 000 |
| M97032000070950 | K203595 | 000 |
| M97032000070900 | K203595 | 000 |
| M97032000070850 | K203595 | 000 |
| M97032000070800 | K203595 | 000 |
| M97032000070750 | K203595 | 000 |
| M97032000070700 | K203595 | 000 |
| M97032000070650 | K203595 | 000 |
| M97032000070600 | K203595 | 000 |
| M97032000070550 | K203595 | 000 |
| M97032000070500 | K203595 | 000 |
| M97032000171050 | K203595 | 000 |
| M97031000000200 | K203595 | 000 |