FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
K Number: K980102
·
Decision Apr 3, 1998
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
30
Review Days
81
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Basic Information
- Device Name
- BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
- K Number
- K980102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biodynamic Technologies, Inc.
- Date Received
- January 12, 1998
- Decision Date
- April 3, 1998
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 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 |
| 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 |
| K962846 | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | Oct 23, 1996 | Substantially Equivalent |