FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
K Number: K161273
·
Decision Jan 25, 2017
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
17
Applicant Total
11
Review Days
265
Basic Information
- Device Name
- StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
- K Number
- K161273
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- May 5, 2016
- Decision Date
- January 25, 2017
- Product Code
- MBB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| MBB | Bone Cement, Antibiotic | FDA class 2 | Orthopedic |
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