FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTERNAL FIXATOR
K Number: K974911
·
Decision Mar 16, 1998
Classifications
1
FEI Numbers
185
Registration Numbers
185
Same Product Code
91
Applicant Total
18
Review Days
75
Basic Information
- Device Name
- EXTERNAL FIXATOR
- K Number
- K974911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AVANTA ORTHOPAEDICS, INC.
- Date Received
- December 31, 1997
- Decision Date
- March 16, 1998
- Product Code
- JDW
- 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 |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDW), ordered by most recent decision date.
XT3 System
FDA 510(k)
FDA Class 2
·Orthopedic
MAVERICK Mini External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MAVERICK External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Steinmann Pins and Kirschner Wires
FDA 510(k)
FDA Class 2
·Orthopedic
Extended HA Half Pins
FDA 510(k)
FDA Class 2
·Orthopedic
Syntec Non-Sterile Steinmann Pins System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by AVANTA ORTHOPAEDICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K030881 | AVANTA CARPAL FUSION PLATING SYSTEM | Apr 10, 2003 | Substantially Equivalent |
| K021859 | WRIST IMPLANT | Dec 2, 2002 | Substantially Equivalent |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | Nov 27, 2002 | Substantially Equivalent |
| K013629 | FINGER JOINT PROSTHESIS | Jan 25, 2002 | Substantially Equivalent |
| K010847 | K'FIX | Jun 19, 2001 | Substantially Equivalent |
| K011819 | RADIAL HEAD IMPLANT | Jun 19, 2001 | Substantially Equivalent |
| K003033 | SCAPHIX, STAPLE, FIXATION, BONE | May 30, 2001 | Substantially Equivalent |
| K010786 | ULNAR HEAD IMPLANT | Apr 11, 2001 | Substantially Equivalent |
| K002644 | RADIAL HEAD IMPLANT | Nov 20, 2000 | Substantially Equivalent |
| K990596 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM | Apr 29, 1999 | Substantially Equivalent |