510(k) K813067
K813067 is an FDA 510(k) premarket notification submitted by Twin City Surgical, Inc. for the device "SPINAL WRENCH". The FDA issued a decision of Substantially Equivalent on November 24, 1981. The device falls under product code HXC (Wrench), a Class I device regulated under 21 CFR 888.4540. Twin City Surgical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1981
- Date Received
- October 30, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrench
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type