The following data is part of a premarket notification filed by Biopoly, Llc with the FDA for Biopoly Great Toe Hemiarthroplasty Implant.
| Device ID | K203634 |
| 510k Number | K203634 |
| Device Name: | BioPoly Great Toe Hemiarthroplasty Implant |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | BioPoly, LLC 7136 Gettysburg Pike Fort Wayne, IN 46804 |
| Contact | Herb Schwartz |
| Correspondent | Dave Mcgurl MCRA, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2021-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850012119418 | K203634 | 000 |
| 00850012119401 | K203634 | 000 |
| 00850012119395 | K203634 | 000 |
| 00850012119388 | K203634 | 000 |
| 00850005618195 | K203634 | 000 |