FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVANTA ORTHOPAEDICS TENDON SPACER
K Number: K964359
·
Decision Mar 25, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
10
Applicant Total
18
Review Days
144
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Basic Information
- Device Name
- AVANTA ORTHOPAEDICS TENDON SPACER
- K Number
- K964359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3025
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avanta Orthopaedics, Inc.
- Date Received
- November 1, 1996
- Decision Date
- March 25, 1997
- Product Code
- HXA
- 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 |
|---|---|---|---|
| HXA | Prosthesis, Tendon, Passive | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXA), ordered by most recent decision date.
Universal Tendon Spacer
FDA 510(k)
FDA Class 2
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SINGLE SIZE TENDON SPACER
FDA 510(k)
FDA Class 2
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OVAL SHAPES
FDA 510(k)
FDA Class 2
·Orthopedic
PHOENIX BONE SCREWS PBS-TYPE SERIES
FDA 510(k)
FDA Class 2
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H-H HUNTER ACTIVE TENDON IMPLANT DC
FDA 510(k)
FDA Class 2
·Orthopedic
H-H HUNTER ACTIVE TENDON IMPLANT PC
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 |