ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM— 510(k) K060683
Substantially EquivalentEndius, Inc.
FDA 510(k) clearance K060683 for ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM, Substantially Equivalent on 2006-04-18. Applicant: Endius, Inc.. Device class: 2.
Clearance details
- Applicant
- Endius, Inc.
- Product code
- Code KWP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plainville, MA, US
Recent devices under product code KWP
view allMore 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
- K073267 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
- K072840 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
- K070282 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.