FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
K Number: K050440
·
Decision Mar 24, 2005
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
20
Review Days
30
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Basic Information
- Device Name
- AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
- K Number
- K050440
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceremed , Inc.
- Date Received
- February 22, 2005
- Decision Date
- March 24, 2005
- Product Code
- MTJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MTJ | Wax, Bone | FDA unclassified | Unknown |
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