FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
K Number: K014001
·
Decision Feb 4, 2003
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
59
Applicant Total
3
Review Days
427
Basic Information
- Device Name
- DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
- K Number
- K014001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORAL OSTEODISTRACTION, L.P.
- Date Received
- December 4, 2001
- Decision Date
- February 4, 2003
- Product Code
- MQN
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| MQN | External Mandibular Fixator And/Or Distractor | FDA class 2 | Dental |
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