The following data is part of a premarket notification filed by 4web, Inc. with the FDA for Osteotomy Truss System (ots).
| Device ID | K172294 |
| 510k Number | K172294 |
| Device Name: | Osteotomy Truss System (OTS) |
| Classification | Plate, Fixation, Bone |
| Applicant | 4Web, Inc. 2801 Network Blvd. Suite 620 Frisco, TX 75034 |
| Contact | Jessee Hunt |
| Correspondent | Rich Jansen Silver Pine Consulting, LLC. 1142 26 1/2 Ave Cumberland, WI 54829 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-31 |
| Decision Date | 2018-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812998024933 | K172294 | 000 |
| 00812998025046 | K172294 | 000 |
| 00812998025053 | K172294 | 000 |
| 00812998025060 | K172294 | 000 |
| 00812998025077 | K172294 | 000 |
| 00812998025084 | K172294 | 000 |
| 00812998027255 | K172294 | 000 |
| 00812998027262 | K172294 | 000 |
| 00812998027279 | K172294 | 000 |
| 00812998025039 | K172294 | 000 |
| 00812998025022 | K172294 | 000 |
| 00812998024940 | K172294 | 000 |
| 00812998024957 | K172294 | 000 |
| 00812998024964 | K172294 | 000 |
| 00812998024971 | K172294 | 000 |
| 00812998024988 | K172294 | 000 |
| 00812998024995 | K172294 | 000 |
| 00812998025008 | K172294 | 000 |
| 00812998025015 | K172294 | 000 |
| 00812998027286 | K172294 | 000 |
| 00812998027293 | K172294 | 000 |
| 00812998027309 | K172294 | 000 |
| 00812998034963 | K172294 | 000 |
| 00812998034970 | K172294 | 000 |
| 00812998034987 | K172294 | 000 |
| 00812998034994 | K172294 | 000 |
| 00812998035007 | K172294 | 000 |
| 00812998035014 | K172294 | 000 |
| 00812998035021 | K172294 | 000 |
| 00812998035038 | K172294 | 000 |
| 00812998034956 | K172294 | 000 |
| 00812998034949 | K172294 | 000 |
| 00812998027316 | K172294 | 000 |
| 00812998027323 | K172294 | 000 |
| 00812998027330 | K172294 | 000 |
| 00812998027347 | K172294 | 000 |
| 00812998027354 | K172294 | 000 |
| 00812998027361 | K172294 | 000 |
| 00812998033966 | K172294 | 000 |
| 00812998034932 | K172294 | 000 |
| 00812998035045 | K172294 | 000 |