The following data is part of a premarket notification filed by Ingen Orthopedics Llc with the FDA for Seviin Reverse Shoulder.
| Device ID | K120374 |
| 510k Number | K120374 |
| Device Name: | SEVIIN REVERSE SHOULDER |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | INGEN ORTHOPEDICS LLC 2650 US HIGHWAY 130 Cranbury, NJ 08512 |
| Contact | Perry Geremakis |
| Correspondent | Perry Geremakis INGEN ORTHOPEDICS LLC 2650 US HIGHWAY 130 Cranbury, NJ 08512 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B59910702400 | K120374 | 000 |
| B59910540130 | K120374 | 000 |
| B59910540100 | K120374 | 000 |
| B59910540060 | K120374 | 000 |
| B59910540030 | K120374 | 000 |
| B59910540000 | K120374 | 000 |
| B59910536160 | K120374 | 000 |
| B59910536130 | K120374 | 000 |
| B59910536100 | K120374 | 000 |
| B59910536060 | K120374 | 000 |
| B59910536030 | K120374 | 000 |
| B59910536000 | K120374 | 000 |
| B59910401090 | K120374 | 000 |
| B59910540160 | K120374 | 000 |
| B59910601000 | K120374 | 000 |
| B59910636000 | K120374 | 000 |
| B59910702350 | K120374 | 000 |
| B59910702300 | K120374 | 000 |
| B59910702250 | K120374 | 000 |
| B59910702200 | K120374 | 000 |
| B59910702150 | K120374 | 000 |
| B59910701290 | K120374 | 000 |
| B59910701250 | K120374 | 000 |
| B59910640100 | K120374 | 000 |
| B59910640040 | K120374 | 000 |
| B59910640000 | K120374 | 000 |
| B59910636100 | K120374 | 000 |
| B59910636040 | K120374 | 000 |
| B59910401000 | K120374 | 000 |