The following data is part of a premarket notification filed by Djo Global with the FDA for Rsp Humeral Socket Insert.
| Device ID | K141006 |
| 510k Number | K141006 |
| Device Name: | RSP HUMERAL SOCKET INSERT |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DJO GLOBAL 9800 METRIC BOULEVARD Austin, TX 78758 |
| Contact | Christine Chesnutt |
| Correspondent | Christine Chesnutt DJO GLOBAL 9800 METRIC BOULEVARD Austin, TX 78758 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912144681 | K141006 | 000 |
| 00888912144643 | K141006 | 000 |
| 00888912144605 | K141006 | 000 |
| 00888912144568 | K141006 | 000 |