510(k) K935593
K935593 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM". The FDA issued a decision of Substantially Equivalent on October 14, 1994. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1994
- Date Received
- November 19, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3690
- Review Panel
- OR
- Submission Type