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 |