MODIFICATION TO ENDIUS ATAVI SYSTEM— 510(k) K061345
Substantially EquivalentEndius, Inc.
FDA 510(k) clearance K061345 for MODIFICATION TO ENDIUS ATAVI SYSTEM, Substantially Equivalent on 2006-06-06. Applicant: Endius, Inc.. Device class: 2.
Clearance details
- Applicant
- Endius, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plainville, MA, US
Recent devices under product code HRX
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 HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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 K061345
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 K061345.
Data sourced from openFDA. This site is unofficial and independent of the FDA.