FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STUART CANNULATED CANCELLOUS BONE FIXATION SCREW
K Number: K881327
·
Decision May 25, 1988
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
2
Review Days
56
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
- STUART CANNULATED CANCELLOUS BONE FIXATION SCREW
- K Number
- K881327
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Stuart Drug & Surgical Supply, Inc.
- Date Received
- March 30, 1988
- Decision Date
- May 25, 1988
- 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 Stuart Drug & Surgical Supply, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K782061 | SPINAL SURGERY INSTRUMENTATION | Mar 21, 1979 | Substantially Equivalent |