ENDIUS TITLE SPINAL FIXATION SYSTEM— 510(k) K021881
Substantially EquivalentEndius, Inc.
FDA 510(k) clearance K021881 for ENDIUS TITLE SPINAL FIXATION SYSTEM, Substantially Equivalent on 2002-07-29. Applicant: Endius, Inc.. Device class: 2.
Clearance details
- Applicant
- Endius, Inc.
- Product code
- Code MNH
- 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 MNH
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 MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.