510(k) K970400
K970400 is an FDA 510(k) premarket notification submitted by Orthofix, Inc. for the device "BONE SOURCE HYDROXYAPATITE". The FDA issued a decision of Substantially Equivalent on May 2, 1997. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Orthofix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1997
- Date Received
- February 3, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Malar
- Device Class
- Class II
- Regulation Number
- 878.3550
- Review Panel
- SU
- Submission Type