FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Hi-Fatigue G Bone Cement
K Number: K192379
·
Decision Nov 27, 2019
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- Hi-Fatigue G Bone Cement
- K Number
- K192379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osartis GmbH
- Date Received
- August 30, 2019
- Decision Date
- November 27, 2019
- Product Code
- LOD
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
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Other Clearances by Osartis GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Nov 20, 2024 | Substantially Equivalent |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | May 18, 2021 | Substantially Equivalent |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Mar 19, 2021 | Substantially Equivalent |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Mar 19, 2021 | Substantially Equivalent |
| K192394 | Hi-Fatigue Bone Cement | Dec 2, 2019 | Substantially Equivalent |