FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StageOne Knee Cement Spacer Molds
K Number: K213287
·
Decision Sep 2, 2022
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
18
Applicant Total
441
Review Days
336
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Basic Information
- Device Name
- StageOne Knee Cement Spacer Molds
- K Number
- K213287
- 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
- October 1, 2021
- Decision Date
- September 2, 2022
- 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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