The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for 101 Neer Type Shoulder.
Device ID | K822771 |
510k Number | K822771 |
Device Name: | 101 NEER TYPE SHOULDER |
Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Applicant | INTERMEDICS ORTHOPEDICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HSD |
CFR Regulation Number | 888.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-14 |
Decision Date | 1982-10-06 |