NUVASIVE SPHERX SYSTEM— 510(k) K082332
Substantially EquivalentNuvasive, Inc.
FDA 510(k) clearance K082332 for NUVASIVE SPHERX SYSTEM, Substantially Equivalent on 2008-10-10. Applicant: Nuvasive, Inc.. Device class: 2.
Clearance details
- Applicant
- Nuvasive, 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
- Special
- Location
- San Diego, CA, US
Recent devices under product code NKB
view all- 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)
- K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Nuvasive, 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 →
Recalls naming K082332
K-number listed on FDA's recall record- Z-0348-2013 — Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0349-2013 — 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0350-2013 — 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0351-2013 — 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0352-2013 — 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0353-2013 — 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0354-2013 — 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0355-2013 — 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0356-2013 — 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0357-2013 — 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0358-2013 — 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0359-2013 — 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0360-2013 — 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0361-2013 — 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0362-2013 — 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0363-2013 — 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0364-2013 — 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0365-2013 — 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0366-2013 — 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Z-0367-2013 — Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082332.
Data sourced from openFDA. This site is unofficial and independent of the FDA.