510(k) K831043
K831043 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "ANDREWS REMOTE CHUCK DRILL". The FDA issued a decision of Substantially Equivalent on April 28, 1983. 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
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1983
- Date Received
- March 31, 1983
- 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