← FDA Medical Device Classifications
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
OBL · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3027
Classification
- FDA Product Code
OBL- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 888.3027
- Review panel
- OR
- Medical specialty
- Orthopedic
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown