510(k) K882871
K882871 is an FDA 510(k) premarket notification submitted by Terray Manufacturing, Inc. for the device "CASF DRILL GUIDE DG 170". The FDA issued a decision of SN on September 23, 1988. The device falls under product code LYQ (Accessories, Fixation, Spinal Intervertebral Body), a Class I device regulated under 21 CFR 888.4540. Terray Manufacturing, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- September 23, 1988
- Date Received
- July 11, 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