The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Kapp Custom Radial Head Elbow Implant.
| Device ID | K030237 |
| 510k Number | K030237 |
| Device Name: | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| 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 | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-23 |
| Decision Date | 2003-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B033KCW92 | K030237 | 000 |
| B033KCHI2614 | K030237 | 000 |
| B033KCHI2612 | K030237 | 000 |
| B033KCHI2315 | K030237 | 000 |
| B033KCHI2313 | K030237 | 000 |
| B033KCHI2311 | K030237 | 000 |
| B033KCHI2014 | K030237 | 000 |
| B033KCHI2012 | K030237 | 000 |
| B033KCHI2010 | K030237 | 000 |
| B033KCHI1813 | K030237 | 000 |
| B033KCHI1811 | K030237 | 000 |
| B033KCHI1809 | K030237 | 000 |
| B033KCHI18110 | K030237 | 000 |
| B033KCHI2616 | K030237 | 000 |
| B033KCSI519 | K030237 | 000 |
| B033KCSI621 | K030237 | 000 |
| B033KCW91 | K030237 | 000 |
| B033KCW82 | K030237 | 000 |
| B033KCW81 | K030237 | 000 |
| B033KCW72 | K030237 | 000 |
| B033KCW71 | K030237 | 000 |
| B033KCW62 | K030237 | 000 |
| B033KCW61 | K030237 | 000 |
| B033KCW52 | K030237 | 000 |
| B033KCW51 | K030237 | 000 |
| B033KCSI925 | K030237 | 000 |
| B033KCSI824 | K030237 | 000 |
| B033KCSI722 | K030237 | 000 |
| B033KCHI18090 | K030237 | 000 |