The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for T2 Flexible Nail.
| Device ID | K082018 |
| 510k Number | K082018 |
| Device Name: | T2 FLEXIBLE NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-16 |
| Decision Date | 2008-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252131113 | K082018 | 000 |
| 07613252130741 | K082018 | 000 |
| 07613252130734 | K082018 | 000 |
| 07613252130727 | K082018 | 000 |
| 07613252130710 | K082018 | 000 |
| 07613252130703 | K082018 | 000 |
| 07613252130697 | K082018 | 000 |
| 07613252130680 | K082018 | 000 |
| 07613252130673 | K082018 | 000 |
| 07613252130666 | K082018 | 000 |
| 07613252130659 | K082018 | 000 |
| 07613252130642 | K082018 | 000 |
| 07613252130635 | K082018 | 000 |
| 07613252130628 | K082018 | 000 |
| 07613252130611 | K082018 | 000 |
| 07613252130758 | K082018 | 000 |
| 07613252130963 | K082018 | 000 |
| 07613252131106 | K082018 | 000 |
| 07613252131090 | K082018 | 000 |
| 07613252131083 | K082018 | 000 |
| 07613252131076 | K082018 | 000 |
| 07613252131069 | K082018 | 000 |
| 07613252131052 | K082018 | 000 |
| 07613252131045 | K082018 | 000 |
| 07613252131038 | K082018 | 000 |
| 07613252131021 | K082018 | 000 |
| 07613252131014 | K082018 | 000 |
| 07613252131007 | K082018 | 000 |
| 07613252130994 | K082018 | 000 |
| 07613252130987 | K082018 | 000 |
| 07613252130970 | K082018 | 000 |
| 07613252130604 | K082018 | 000 |