FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K Number: K024086
·
Decision Jan 9, 2003
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
34
Review Days
29
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
- PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
- K Number
- K024086
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Orthopedics, Inc.
- Date Received
- December 11, 2002
- Decision Date
- January 9, 2003
- 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 Biomet Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080528 | E-POLY TIBIAL BEARINGS | Jun 17, 2008 | Substantially Equivalent |
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | Jan 14, 2008 | Substantially Equivalent |
| K070955 | ACID ETCHED LAG SCREWS | Oct 12, 2007 | Substantially Equivalent |
| K033355 | LACTOSCREW SCREW ANCHOR | Jun 30, 2004 | Substantially Equivalent |
| K032286 | CALCIGEN PSI BONE GRAFT SUBSTITUTE | Nov 20, 2003 | Substantially Equivalent |
| K030048 | HA PMI FEMORAL HIP STEM | Feb 5, 2003 | Substantially Equivalent |
| K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM | Dec 13, 2002 | Substantially Equivalent |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Dec 11, 2002 | Substantially Equivalent |
| K023357 | ARCPM 1050 RESIN-HIPS | Nov 6, 2002 | Substantially Equivalent |
| K021661 | RINGLOC CONSTRAINED LINERS | Oct 25, 2002 | Substantially Equivalent |