FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION
K Number: K950695
·
Decision Jul 21, 1995
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
2
Review Days
157
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Basic Information
- Device Name
- DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION
- K Number
- K950695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Depuy Motech
- Date Received
- February 14, 1995
- Decision Date
- July 21, 1995
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Depuy Motech
| K Number | Device Name | ||
|---|---|---|---|
| K950697 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION | Jun 22, 1995 | Substantially Equivalent |