FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
K Number: K031701
·
Decision Jul 8, 2004
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
6
Applicant Total
29
Review Days
402
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Basic Information
- Device Name
- OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
- K Number
- K031701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed LP
- Date Received
- June 2, 2003
- Decision Date
- July 8, 2004
- Product Code
- NEI
- 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 |
|---|---|---|---|
| NEI | Prosthesis, Condyle, Mandibular, Temporary | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEI), ordered by most recent decision date.
STRYKER TEMPORARY CONDYLAR PROSTHESIS
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MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
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SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
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ADD-ON CONDYLE
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KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
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·Dental
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
FDA 510(k)
FDA Class 2
·Dental
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| K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | Aug 17, 2010 | Substantially Equivalent |