FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
K Number: K962846
·
Decision Oct 23, 1996
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
56
Applicant Total
30
Review Days
93
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Basic Information
- Device Name
- EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
- K Number
- K962846
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biodynamic Technologies, Inc.
- Date Received
- July 22, 1996
- Decision Date
- October 23, 1996
- Product Code
- LXT
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | FDA class 2 | Orthopedic |
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Other Clearances by Biodynamic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM | Mar 31, 1999 | Substantially Equivalent |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | Mar 17, 1999 | Substantially Equivalent |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | Mar 17, 1999 | Substantially Equivalent |
| K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Jun 1, 1998 | Substantially Equivalent |
| K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | Apr 3, 1998 | Substantially Equivalent |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | Mar 12, 1998 | Substantially Equivalent for Some Indications |
| K972403 | BTI CORTICAL BONE SCREWS | Aug 29, 1997 | Substantially Equivalent |
| K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | Nov 13, 1996 | Substantially Equivalent |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | Nov 4, 1996 | Substantially Equivalent |