GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System— 510(k) K163096
Substantially EquivalentGpc Medical Limited
FDA 510(k) clearance K163096 for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System, Substantially Equivalent on 2017-03-31. Applicant: Gpc Medical Limited. Device class: 2.
Clearance details
- Applicant
- Gpc Medical Limited
- 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
- New Delhi, IN
Recent devices under product code NKB
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- 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 Gpc Medical Limited
view all- K203811 — GPC Intraheal Intramedullary Nailing System
- K210198 — GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive
- K143245 — GPC Intramedullary Nailing Systems
Adverse 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.