The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Mcafee Spinal System For Posterior Applications.
| Device ID | K912837 |
| 510k Number | K912837 |
| Device Name: | MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-26 |
| Decision Date | 1992-08-26 |