510(k) K853033
K853033 is an FDA 510(k) premarket notification submitted by A.W. Showell (Surgicraft) , Ltd. for the device "HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 1985. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. A.W. Showell (Surgicraft) , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1985
- Date Received
- July 18, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type