FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
CANCELLOUS BONE SCREW
K Number: K934615
·
Decision Apr 25, 1994
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
47
Review Days
210
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
- CANCELLOUS BONE SCREW
- K Number
- K934615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Onyx Medical Corp.
- Date Received
- September 27, 1993
- Decision Date
- April 25, 1994
- 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 Onyx Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K942022 | FACE-IT SHIELD | Jul 8, 1994 | Substantially Equivalent |
| K931690 | SPOON PLATE | Jun 7, 1994 | Substantially Equivalent for Some Indications |
| K934614 | MINI FRAGMENT PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931692 | T-PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931684 | EPIPHYSIS PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931680 | CANNULATED CANCELLOUS SCREW | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931679 | BUTTRESS PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931683 | CLOVERLEAF PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931693 | 1/3 TUBULAR PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931687 | MULTIPLE FRAGMENT PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |