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 | K962289 |
510k Number | K962289 |
Device Name: | SELECT SHOULDER COCR HUMERAL STEM COMPONENT |
Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
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 | HSD |
CFR Regulation Number | 888.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-14 |
Decision Date | 1996-08-29 |
Summary: | summary |