FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
K Number: K042278
·
Decision Jan 28, 2005
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
59
Applicant Total
3
Review Days
158
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
- K Number
- K042278
- 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
- August 23, 2004
- Decision Date
- January 28, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQN), ordered by most recent decision date.
KLS Martin IPS Distraction
FDA 510(k)
FDA Class 2
·Dental
DePuy Synthes Maxillofacial Portfolio - MR Conditional
FDA 510(k)
FDA Class 2
·Dental
Stryker Pediatric Mandibular Distractor 2
FDA 510(k)
FDA Class 2
·Dental
Craniomaxillofacial Distraction System (CMFD)
FDA 510(k)
FDA Class 2
·Dental
Internal Distraction - Sterile
FDA 510(k)
FDA Class 2
·Dental
Mandible External Fixator - MR Conditional
FDA 510(k)
FDA Class 2
·Dental