The following data is part of a premarket notification filed by Arrow Products, Inc. with the FDA for Arrowhead Fixation Device.
| Device ID | K100926 |
| 510k Number | K100926 |
| Device Name: | ARROWHEAD FIXATION DEVICE |
| Classification | Pin, Fixation, Smooth |
| Applicant | ARROW PRODUCTS, INC. 2593 LAKE ERMA DRIVE Hampton, GA 30228 |
| Contact | Scott R Roman |
| Correspondent | Scott R Roman ARROW PRODUCTS, INC. 2593 LAKE ERMA DRIVE Hampton, GA 30228 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-05 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855967006196 | K100926 | 000 |
| 00855967006011 | K100926 | 000 |
| 00855967006028 | K100926 | 000 |
| 00855967006035 | K100926 | 000 |
| 00855967006042 | K100926 | 000 |
| 00855967006059 | K100926 | 000 |
| 00855967006066 | K100926 | 000 |
| 00855967006073 | K100926 | 000 |
| 00855967006080 | K100926 | 000 |
| 00855967006097 | K100926 | 000 |
| 00855967006110 | K100926 | 000 |
| 00855967006127 | K100926 | 000 |
| 00855967006134 | K100926 | 000 |
| 00855967006141 | K100926 | 000 |
| 00855967006158 | K100926 | 000 |
| 00855967006165 | K100926 | 000 |
| 00855967006172 | K100926 | 000 |
| 00855967006189 | K100926 | 000 |
| 00855967006004 | K100926 | 000 |