K882078 is an FDA 510(k) clearance for the SPINAL SURGERY FRAME. This device is classified as a Operating Room Accessories Table Tray (Class I - General Controls, product code FWZ).
Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on June 16, 1988, 30 days after receiving the submission on May 17, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance..
| 510(k) Number | K882078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 1988 |
| Decision Date | June 16, 1988 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FWZ — Operating Room Accessories Table Tray |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance. |