The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Cm-6 Total Hip System.
| Device ID | K861930 |
| 510k Number | K861930 |
| Device Name: | CM-6 TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304255074 | K861930 | 000 |
| 00880304255067 | K861930 | 000 |
| 00880304255050 | K861930 | 000 |
| 00880304255043 | K861930 | 000 |