510(k) K880264
K880264 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "BONE SUTURE FIXATION DEVICE". The FDA issued a decision of SN on March 23, 1988. The device falls under product code HXY (Brace, Drill), a Class I device regulated under 21 CFR 888.4540. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 23, 1988
- Date Received
- January 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brace, Drill
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type