FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K Number: K974756
·
Decision Mar 12, 1998
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
30
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
- K Number
- K974756
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Biodynamic Technologies, Inc.
- Date Received
- December 19, 1997
- Decision Date
- March 12, 1998
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.
VEOFIX Snap Off Screw
FDA 510(k)
FDA Class 2
·Orthopedic
CoLink® & CoLag® Non-Sterile Screws
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Compression Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Beaming System
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Threaded Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN Nail; APTUS K-Wire System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| 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 |