FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K Number: K953730
·
Decision Nov 9, 1995
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
655
Applicant Total
206
Review Days
91
Basic Information
- Device Name
- CODMAN ANTERIOR CERVICAL PLATE SYSTEM
- K Number
- K953730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- JOHNSON & JOHNSON PROFESSIONALS, INC.
- Date Received
- August 10, 1995
- Decision Date
- November 9, 1995
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Jul 1, 1998 | Substantially Equivalent |
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