FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K Number: K043555
·
Decision Apr 12, 2005
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
59
Applicant Total
402
Review Days
106
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Basic Information
- Device Name
- SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
- K Number
- K043555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- December 27, 2004
- Decision Date
- April 12, 2005
- 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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| K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Dec 20, 2010 | Substantially Equivalent |
| K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Dec 16, 2010 | Substantially Equivalent |
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| K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM | Aug 3, 2010 | Substantially Equivalent |