510(k) K964226
K964226 is an FDA 510(k) premarket notification submitted by Landos, Inc. for the device "MEMORY STAPLE (20 SIZES AVAILABLE)". The FDA issued a decision of Substantially Equivalent on August 5, 1997. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Landos, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1997
- Date Received
- October 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type