The following data is part of a premarket notification filed by Wishbone Medical, Inc. with the FDA for Wishbone K-wire System.
| Device ID | K173013 |
| 510k Number | K173013 |
| Device Name: | WishBone K-Wire System |
| Classification | Pin, Fixation, Smooth |
| Applicant | WishBone Medical, Inc. 2150 North Pointe Drive Warsaw, IN 46582 |
| Contact | Gary Barnett |
| Correspondent | Gary Barnett WishBone Medical, Inc. 2150 North Pointe Drive Warsaw, IN 46582 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B562KITKWILBONE0 | K173013 | 000 |
| B56213904002520S10 | K173013 | 000 |
| B56213904002520S00 | K173013 | 000 |
| B56213904002020S10 | K173013 | 000 |
| B56213904002020S00 | K173013 | 000 |
| B56213904001620S10 | K173013 | 000 |
| B56213904001620S00 | K173013 | 000 |
| B56213904001220S10 | K173013 | 000 |
| B56213904001220S00 | K173013 | 000 |
| B562PK301EXT1250 | K173013 | 000 |
| B562PK301ELB2000 | K173013 | 000 |
| B562HDRASS150 | K173013 | 000 |
| B562HDRASS15US0 | K173013 | 000 |
| B562KITKWIEXMED0 | K173013 | 000 |
| B562KITKWIEXLAR0 | K173013 | 000 |
| B562KITKWIELBOW0 | K173013 | 000 |
| B562KITKWIEXSML0 | K173013 | 000 |
| B562PKKWEXTUS0 | K173013 | 000 |
| B562PKKWEXT0 | K173013 | 000 |
| B562PKKWELBUS0 | K173013 | 000 |
| B562PKKWELB0 | K173013 | 000 |
| B562KWSBUS0 | K173013 | 000 |
| B562KWSB0 | K173013 | 000 |
| B562PK301ELB1600 | K173013 | 000 |