FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL SPINAL CORRECTION
K Number: K760649
·
Decision Oct 5, 1976
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
5
Applicant Total
303
Review Days
20
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Basic Information
- Device Name
- TOTAL SPINAL CORRECTION
- K Number
- K760649
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- September 15, 1976
- Decision Date
- October 5, 1976
- Product Code
- JDN
- 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 |
|---|---|---|---|
| JDN | Implant, Fixation Device, Spinal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
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FDA Class 2
·Orthopedic
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|---|---|---|---|
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