510(k) K922194
K922194 is an FDA 510(k) premarket notification submitted by Osteo AG for the device "OSTEO STEINMANN PIN". The FDA issued a decision of Substantially Equivalent on July 23, 1992. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Osteo AG has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1992
- Date Received
- May 11, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type