ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM— 510(k) K073267
Substantially EquivalentEndius, Inc.
FDA 510(k) clearance K073267 for ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM, Substantially Equivalent on 2008-01-30. Applicant: Endius, Inc.. Device class: 2.
Clearance details
- Applicant
- Endius, 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
- Plainville, MA, US
Recent devices under product code NKB
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- K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
More clearances from Endius, Inc.
view all- K080258 — MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K073510 — ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
- K072840 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
- K070282 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K070367 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
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.