The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Hemicap Mtp Resurfacing Hemi-arthroplasty Implant.
| Device ID | K131377 |
| 510k Number | K131377 |
| Device Name: | HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038 |
| Contact | Dawn J Wilson |
| Correspondent | Dawn J Wilson ARTHROSURFACE, INC. 28 FORGE PARKWAY Franklin, MA 02038 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-14 |
| Decision Date | 2013-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5289P15S180W0 | K131377 | 000 |
| M52891522535W0 | K131377 | 000 |
| M52891522535A0 | K131377 | 000 |
| M52891522040W0 | K131377 | 000 |
| M52891522040A0 | K131377 | 000 |
| M52891522030W0 | K131377 | 000 |
| M52891522030A0 | K131377 | 000 |
| M52891521535W0 | K131377 | 000 |
| M52891521535A0 | K131377 | 000 |
| M52891521525W0 | K131377 | 000 |
| M52891521525A0 | K131377 | 000 |
| M52890950018W0 | K131377 | 000 |
| M52891522545A0 | K131377 | 000 |
| M52891522545W0 | K131377 | 000 |
| M5289F15PA01W0 | K131377 | 000 |
| M5289P15PB02W0 | K131377 | 000 |
| M5289P15PB01W0 | K131377 | 000 |
| M5289P15PA02W0 | K131377 | 000 |
| M5289M522545W0 | K131377 | 000 |
| M5289M522545A0 | K131377 | 000 |
| M5289M522535W0 | K131377 | 000 |
| M5289M522535A0 | K131377 | 000 |
| M5289M521545W0 | K131377 | 000 |
| M5289M521545A0 | K131377 | 000 |
| M5289M521535W0 | K131377 | 000 |
| M5289M521535A0 | K131377 | 000 |
| M52890950018A0 | K131377 | 000 |