510(k) K030237
K030237 is an FDA 510(k) premarket notification submitted by Kapp Surgical Instrument, Inc. for the device "KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT". The FDA issued a decision of Substantially Equivalent on August 29, 2003. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Kapp Surgical Instrument, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2003
- Date Received
- January 23, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device Class
- Class II
- Regulation Number
- 888.3170
- Review Panel
- OR
- Submission Type