The following data is part of a premarket notification filed by U&i Corp. with the FDA for Dyna Locking Ankle Nail.
| Device ID | K120419 |
| 510k Number | K120419 |
| Device Name: | DYNA LOCKING ANKLE NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | U&I CORP. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 480-859 |
| Contact | Gyeong-je Kwon |
| Correspondent | Gyeong-je Kwon U&I CORP. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, KR 480-859 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-10 |
| Decision Date | 2012-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800015913751 | K120419 | 000 |
| 08800015913614 | K120419 | 000 |
| 08800015913621 | K120419 | 000 |
| 08800015913638 | K120419 | 000 |
| 08800015913645 | K120419 | 000 |
| 08800015913652 | K120419 | 000 |
| 08800015913669 | K120419 | 000 |
| 08800015913676 | K120419 | 000 |
| 08800015913683 | K120419 | 000 |
| 08800015913690 | K120419 | 000 |
| 08800015913706 | K120419 | 000 |
| 08800015913713 | K120419 | 000 |
| 08800015913720 | K120419 | 000 |
| 08800015913737 | K120419 | 000 |
| 08800015913744 | K120419 | 000 |
| 08800015913607 | K120419 | 000 |