BLACKSTONE PEDICLE SCREW SYSTEM
FDA 510(k) clearance K081684 · decided 2008-09-15
Clearance details
- K-number
- K081684
- Device name
- BLACKSTONE PEDICLE SCREW SYSTEM
- Applicant
- Blackstone Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-17
- Decision date
- 2008-09-15
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Blackstone Medical
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
| Record | Firm | Date |
|---|---|---|
| Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usa recall (Z-0855-2014) | Orthofix, Inc. | 2014-01-28 |
| BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapp recall (Z-1674-2011) | Orthofix Inc | 2011-03-16 |
| ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Par recall (Z-1608-2011) | Orthofix Inc | 2011-03-08 |