510(k) K884406
K884406 is an FDA 510(k) premarket notification submitted by De Medica Mfg., Inc. for the device "TRACER HIP PINNING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 28, 1988. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. De Medica Mfg., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1988
- Date Received
- October 19, 1988
- 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