SYNTHES SCOUT TACK FIXATION— 510(k) K111048

Unknown

Synthes Spine

FDA 510(k) clearance K111048 for SYNTHES SCOUT TACK FIXATION, Unknown on 2012-06-14. Applicant: Synthes Spine. Device class: 2.

Clearance details

Applicant: Synthes Spine
Product code: Code OMR
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2011-04-15
Decision date: 2012-06-14
Decision: Unknown
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMR

K111137 — HYDROFIX VASO SHIELD2011-05-20
K101805 — HYDROFIX VASO SHIELD2011-04-08
K103558 — SYNTHES SCOUT VESSEL GUARD2011-02-18
K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-06102010-07-28
K100984 — XYLOS VESSEL GUARD2010-07-07

More clearances from Synthes Spine

K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS2012-12-17
K120838 — SYNTHES MATRIX SYSTEM2012-07-31
K120928 — SYNTHES MATRIX SYSTEM2012-05-18
K120571 — SYNTHES USS CONNECTOR2012-05-14
K113149 — SYNTHES USS CONNECTORS2012-02-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.