MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM— 510(k) K080258

Clearance details

Applicant

Endius, Inc.

Product code

Product code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2008-01-31

Decision date

2008-03-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plainville, MA, US

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• K073510 — ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM2008-02-11
• K073267 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM2008-01-30
• K072840 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM2007-12-07
• K070282 — ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM2007-09-06
• K070367 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM2007-04-12

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →