Synapse Occipital-Cervical-Thoracic (OCT) System— 510(k) K142838
Substantially EquivalentSynthes USA Products, LLC
FDA 510(k) clearance K142838 for Synapse Occipital-Cervical-Thoracic (OCT) System, Substantially Equivalent on 2015-01-20. Applicant: Synthes USA Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes USA Products, LLC
- Product code
- Code NKG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3075
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
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Adverse events under product code NKG
product code NKG- Death
- 15
- Injury
- 1,090
- Malfunction
- 529
- Total
- 1,634
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 K142838
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142838.
Data sourced from openFDA. This site is unofficial and independent of the FDA.