FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
BonOs Inject Bone Cement; NEO Pedicle Screw System
K Number: K212489
·
Decision Oct 28, 2021
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
16
Applicant Total
3
Review Days
80
Basic Information
- Device Name
- BonOs Inject Bone Cement; NEO Pedicle Screw System
- K Number
- K212489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neo Medical SA
- Date Received
- August 9, 2021
- Decision Date
- October 28, 2021
- Product Code
- PML
- 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 |
|---|---|---|---|
| PML | Bone Cement, Posterior Screw Augmentation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PML), ordered by most recent decision date.
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
PERLA® TL System; TEKTONA® HV US Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
VADER® Pedicle System, G21 Cement
FDA 510(k)
FDA Class 2
·Orthopedic
Invictus® Bone Cement, Invictus Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
BonOs® Inject Bone Cement; NEO Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic