The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Select Shoulder Cocr Humeral Stem Component.
| Device ID | K962315 |
| 510k Number | K962315 |
| Device Name: | SELECT SHOULDER COCR HUMERAL STEM COMPONENT |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-09-03 |
| Summary: | summary |