The following data is part of a premarket notification filed by Hand Innovations, Llc. with the FDA for Multidirectional Threaded Peg.
| Device ID | K060864 |
| 510k Number | K060864 |
| Device Name: | MULTIDIRECTIONAL THREADED PEG |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-30 |
| Decision Date | 2006-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868011412 | K060864 | 000 |
| 00887868546662 | K060864 | 000 |
| 00887868546655 | K060864 | 000 |
| 00887868546648 | K060864 | 000 |
| 00887868546631 | K060864 | 000 |
| 00887868546624 | K060864 | 000 |
| 00887868546617 | K060864 | 000 |
| 00887868546600 | K060864 | 000 |
| 00887868546587 | K060864 | 000 |
| 00887868546563 | K060864 | 000 |
| 00887868546679 | K060864 | 000 |
| 00887868011283 | K060864 | 000 |
| 00887868011405 | K060864 | 000 |
| 00887868011399 | K060864 | 000 |
| 00887868011382 | K060864 | 000 |
| 00887868011375 | K060864 | 000 |
| 00887868011368 | K060864 | 000 |
| 00887868011351 | K060864 | 000 |
| 00887868011344 | K060864 | 000 |
| 00887868011320 | K060864 | 000 |
| 00887868011306 | K060864 | 000 |
| 00887868546549 | K060864 | 000 |