510(k) K001476
K001476 is an FDA 510(k) premarket notification submitted by Spinalight, Inc. for the device "TORQUE INSTRUMENT, MODEL 8500". The FDA issued a decision of Substantially Equivalent on August 4, 2000. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Spinalight, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2000
- Date Received
- May 11, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manipulator, Plunger-Like Joint
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type