FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stryker Pediatric Mandibular Distractor 2
K Number: K181504
·
Decision Sep 11, 2018
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
59
Applicant Total
92
Review Days
96
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Basic Information
- Device Name
- Stryker Pediatric Mandibular Distractor 2
- K Number
- K181504
- 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
- June 7, 2018
- Decision Date
- September 11, 2018
- 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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