510(k) K883784
K883784 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE". The FDA issued a decision of SN on April 6, 1989. The device falls under product code LYQ (Accessories, Fixation, Spinal Intervertebral Body), a Class I device regulated under 21 CFR 888.4540. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- April 6, 1989
- Date Received
- September 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Fixation, Spinal Intervertebral Body
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type