FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K Number: K933881
·
Decision Jul 12, 1994
Classifications
1
FEI Numbers
330
Registration Numbers
330
Same Product Code
429
Applicant Total
303
Review Days
336
Basic Information
- Device Name
- DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
- K Number
- K933881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEPUY, INC.
- Date Received
- August 10, 1993
- Decision Date
- July 12, 1994
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K020541 | AGILITY ANKLE REVISION PROSTHESIS | May 20, 2002 | Substantially Equivalent |
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