K931037 is an FDA 510(k) clearance for the WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100). This device is classified as a Operating Room Accessories Table Tray (Class I - General Controls, product code FWZ).
Submitted by Whitmore Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on July 30, 1993, 151 days after receiving the submission on March 1, 1993.
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 | K931037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1993 |
| Decision Date | July 30, 1993 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |