The following data is part of a premarket notification filed by Accufix Surgical, Inc. with the FDA for Accu-joint Hemi Implant.
| Device ID | K200951 |
| 510k Number | K200951 |
| Device Name: | Accu-Joint Hemi Implant |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | Accufix Surgical, Inc. 385 Main Street, Suite 10 West Haven, CT 06516 |
| Contact | Michael Parisi |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-09 |
| Decision Date | 2020-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850044114245 | K200951 | 000 |
| 00850044114122 | K200951 | 000 |
| 00850044114115 | K200951 | 000 |
| 00850044114108 | K200951 | 000 |
| 00850044114092 | K200951 | 000 |
| 00850044114085 | K200951 | 000 |
| 00850044114078 | K200951 | 000 |
| 00850044114917 | K200951 | 000 |
| 00850044114900 | K200951 | 000 |
| 00850044114139 | K200951 | 000 |
| 00850044114146 | K200951 | 000 |
| 00850044114153 | K200951 | 000 |
| 00850044114238 | K200951 | 000 |
| 00850044114221 | K200951 | 000 |
| 00850044114214 | K200951 | 000 |
| 00850044114207 | K200951 | 000 |
| 00850044114191 | K200951 | 000 |
| 00850044114184 | K200951 | 000 |
| 00850044114177 | K200951 | 000 |
| 00850044114160 | K200951 | 000 |
| 00850044114894 | K200951 | 000 |