SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM— 510(k) K094002
Substantially EquivalentSpartek Medical, Inc.
FDA 510(k) clearance K094002 for SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM, Substantially Equivalent on 2010-05-07. Applicant: Spartek Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Spartek Medical, Inc.
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code NKB
view all- K262091 — FRAXION Spinal Fixation System
- K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology +1 more
- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
More clearances from Spartek Medical, Inc.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.