OBLClass II
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
21 CFR 888.3027 / Orthopedic
OBL is the FDA product code for Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty, a class II device type, regulated under 21 CFR 888.3027. FDA's definition for this code reads: "Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OBL
- Device name
- Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
- FDA definition
- Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
- Regulation
- 21 CFR 888.3027
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code OBL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
Applicants with the most clearances
Product code OBL| Applicant | Clearances |
|---|---|
| Spine Wave Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OBL.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.