The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Kapp Custom Ulnar Head Wrist Implant.
| Device ID | K033930 |
| 510k Number | K033930 |
| Device Name: | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| Applicant | KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. Cleveland, OH 44128 |
| Contact | Albert Santilli |
| Correspondent | Albert Santilli KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. Cleveland, OH 44128 |
| Product Code | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-18 |
| Decision Date | 2004-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B033KCUS5276 | K033930 | 000 |
| B033KCS52 | K033930 | 000 |
| B033KCS61 | K033930 | 000 |
| B033KCS62 | K033930 | 000 |
| B033KCS71 | K033930 | 000 |
| B033KCS72 | K033930 | 000 |
| B033KCUC4854 | K033930 | 000 |
| B033KCUC4865 | K033930 | 000 |
| B033KCUC4876 | K033930 | 000 |
| B033KCUH1314 | K033930 | 000 |
| B033KCUH1515 | K033930 | 000 |
| B033KCUH1617 | K033930 | 000 |
| B033KCUS5254 | K033930 | 000 |
| B033KCUS5265 | K033930 | 000 |
| B033KCS51 | K033930 | 000 |