FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DANEK RIGID ARTHROSCOPE
K Number: K950501
·
Decision May 12, 1995
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
41
Review Days
95
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Basic Information
- Device Name
- DANEK RIGID ARTHROSCOPE
- K Number
- K950501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sofamor Danek USA,Inc.
- Date Received
- February 6, 1995
- Decision Date
- May 12, 1995
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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| K991036 | DANEK PLATE AND SCREW SYSTEM | Sep 14, 1999 | Substantially Equivalent |
| K991198 | DYNA-LOK PLUS SPINAL SYSTEM | Aug 27, 1999 | Substantially Equivalent |
| K991364 | MODIFICATION TO TENOR SPINAL SYSTEM-PLATES | May 19, 1999 | Substantially Equivalent |
| K981676 | CD HORIZON SPINAL SYSTEM | Jan 28, 1999 | Substantially Equivalent |
| K980184 | CD SPINAL SYSTEM | Dec 18, 1998 | Substantially Equivalent |
| K983672 | DYNA-LOK SPINAL SYSTEM | Dec 16, 1998 | Substantially Equivalent |
| K983706 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM | Nov 12, 1998 | Substantially Equivalent |