510(k) K991037
K991037 is an FDA 510(k) premarket notification submitted by Modular Cutting Systems, Inc. for the device "EUCLID REDUCTION AND GUIDANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 1999. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Modular Cutting Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1999
- Date Received
- March 29, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nail, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type