The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Neer-iii Proximal Humerus.
| Device ID | K873073 |
| 510k Number | K873073 |
| Device Name: | KIRSCHNER NEER-III PROXIMAL HUMERUS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Contact | Sam Son |
| Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-06 |
| Decision Date | 1987-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304195912 | K873073 | 000 |
| 00880304195844 | K873073 | 000 |
| 00880304005136 | K873073 | 000 |
| 00880304004870 | K873073 | 000 |