K875291 is an FDA 510(k) clearance for the SPINAL SURGERY FRAME. This device is classified as a Table And Attachments, Operating-room (Class I - General Controls, product code BWN).
Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on January 22, 1988, 23 days after receiving the submission on December 30, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K875291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1987 |
| Decision Date | January 22, 1988 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | BWN — Table And Attachments, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |