FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K Number: K133398
·
Decision Mar 20, 2014
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
59
Applicant Total
92
Review Days
134
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Basic Information
- Device Name
- STRYKER PEDIATRIC MANDIBLE DISTRACTOR
- K Number
- K133398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker
- Date Received
- November 6, 2013
- Decision Date
- March 20, 2014
- 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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