The following data is part of a premarket notification filed by Ingen Orthopedics Llc with the FDA for Seviin Surface Replacement Shoulder.
| Device ID | K130635 |
| 510k Number | K130635 |
| Device Name: | SEVIIN SURFACE REPLACEMENT SHOULDER |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | INGEN ORTHOPEDICS LLC 2650 US HIGHWAY 130 Cranbury, NJ 08512 |
| Contact | Perry A Geremakis |
| Correspondent | Perry A Geremakis INGEN ORTHOPEDICS LLC 2650 US HIGHWAY 130 Cranbury, NJ 08512 |
| Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-08-26 |
| Summary: | summary |