The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Cap 7.0mm Mtp Resurfacing Hemi-arthroplasty.
| Device ID | K063370 |
| 510k Number | K063370 |
| Device Name: | CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY |
| 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 | 2006-11-08 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52891222030W0 | K063370 | 000 |
| M52890800016A0 | K063370 | 000 |
| M52890800016W0 | K063370 | 000 |
| M52891221015A0 | K063370 | 000 |
| M52891221015W0 | K063370 | 000 |
| M52891221020A0 | K063370 | 000 |
| M52891221020W0 | K063370 | 000 |
| M52891221520A0 | K063370 | 000 |
| M52891221520W0 | K063370 | 000 |
| M52891221525A0 | K063370 | 000 |
| M52891221525W0 | K063370 | 000 |
| M52891222025A0 | K063370 | 000 |
| M52891222025W0 | K063370 | 000 |
| M52891222030A0 | K063370 | 000 |
| M52890700013W0 | K063370 | 000 |