The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Rigidfix Curve St Acl Pla Cross Pin System, Rigidfix Curve St Acl Peek Cross Pin System.
| Device ID | K130105 |
| 510k Number | K130105 |
| Device Name: | RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Julie Vafides |
| Correspondent | Julie Vafides DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-15 |
| Decision Date | 2013-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705020017 | K130105 | 000 |
| 20886705020000 | K130105 | 000 |
| 10886705020164 | K130105 | 000 |
| 10886705020157 | K130105 | 000 |
| 10886705020140 | K130105 | 000 |
| 10886705019977 | K130105 | 000 |
| 10886705019960 | K130105 | 000 |
| 10886705019953 | K130105 | 000 |