The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Stealthfix Intraosseous Fixation System.
| Device ID | K220181 |
| 510k Number | K220181 |
| Device Name: | StealthFix Intraosseous Fixation System |
| Classification | Staple, Fixation, Bone |
| Applicant | Nextremity Solutions, Inc. 1195 Polk Drive Warsaw, IN 46582 |
| Contact | Elise Fox |
| Correspondent | Elise Fox Nextremity Solutions, Inc. 1195 Polk Drive Warsaw, IN 46582 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-21 |
| Decision Date | 2022-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810082893885 | K220181 | 000 |
| 00810082893991 | K220181 | 000 |
| 00810082894004 | K220181 | 000 |
| 00810082894011 | K220181 | 000 |
| 00810082894028 | K220181 | 000 |
| 00810082894035 | K220181 | 000 |
| 00810082894042 | K220181 | 000 |
| 00810082894059 | K220181 | 000 |
| 00810082894066 | K220181 | 000 |
| 00810082893984 | K220181 | 000 |
| 00810082893977 | K220181 | 000 |
| 00810082893892 | K220181 | 000 |
| 00810082893908 | K220181 | 000 |
| 00810082893915 | K220181 | 000 |
| 00810082893922 | K220181 | 000 |
| 00810082893939 | K220181 | 000 |
| 00810082893946 | K220181 | 000 |
| 00810082893953 | K220181 | 000 |
| 00810082893960 | K220181 | 000 |
| 00810082894073 | K220181 | 000 |
| 00810082894080 | K220181 | 000 |
| 00810082894097 | K220181 | 000 |
| 00810082894202 | K220181 | 000 |
| 00810082894219 | K220181 | 000 |
| 00810082894226 | K220181 | 000 |
| 00810082894233 | K220181 | 000 |
| 00810082896060 | K220181 | 000 |
| 00810082896077 | K220181 | 000 |
| 00810082896114 | K220181 | 000 |
| 00810082896121 | K220181 | 000 |
| 00810082894196 | K220181 | 000 |
| 00810082894189 | K220181 | 000 |
| 00810082894103 | K220181 | 000 |
| 00810082894110 | K220181 | 000 |
| 00810082894127 | K220181 | 000 |
| 00810082894134 | K220181 | 000 |
| 00810082894141 | K220181 | 000 |
| 00810082894158 | K220181 | 000 |
| 00810082894165 | K220181 | 000 |
| 00810082894172 | K220181 | 000 |
| 00810082896138 | K220181 | 000 |