BonOs Inject Bone Cement; NEO Pedicle Screw System
FDA 510(k) clearance K212489 · decided 2021-10-28
Clearance details
- K-number
- K212489
- Device name
- BonOs Inject Bone Cement; NEO Pedicle Screw System
- Applicant
- Neo Medical SA
- Decision
- Substantially Equivalent
- Date received
- 2021-08-09
- Decision date
- 2021-10-28
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- PML
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Villette (Lavaux), CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Neo Medical SA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.