FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOSMO Femoral Stem
K Number: K202768
·
Decision Apr 1, 2021
Classifications
1
FEI Numbers
284
Registration Numbers
284
Same Product Code
522
Applicant Total
4
Review Days
192
Basic Information
- Device Name
- KOSMO Femoral Stem
- K Number
- K202768
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- b-One Ortho Corp.
- Date Received
- September 21, 2020
- Decision Date
- April 1, 2021
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by b-One Ortho Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | Jan 28, 2019 | Substantially Equivalent |
| K180446 | b-ONE Total Knee System | Oct 12, 2018 | Substantially Equivalent |
| K173380 | b-ONE® Total Hip System | Aug 30, 2018 | Substantially Equivalent |