Product Code: NDK


Products Classified as NDK

4637System, External Fixator (with Metallic Invasive Components)Smooth Or Threaded Metallic Bone Fixation Fastener.

Total Product Life Cycle (TPLC) Devices

4637System, External Fixator (with Metallic Invasive Components)Smooth Or Threaded Metallic Bone Fixation Fastener.

FDA Consensus Standards

System, External Fixator (With Metallic Invasive Components) [34059]21 CFR §888.3040 🔎
System, External Fixator (With Metallic Invasive Components) [34070]21 CFR §888.3040 🔎
System, External Fixator (With Metallic Invasive Components) [37410]21 CFR §888.3040 🔎
System, External Fixator (With Metallic Invasive Components) [37411]21 CFR §888.3040 🔎

Pre-market Notifications for NDK

K140649VECTRIX EXTERNAL FIXATOR3D MEDICAL CONCEPTS, LLC
K122208EXTERNAL FIXATOR SYSTEMCHRISTOPHER D. ENDARA
K101375TRIMED X-FIXTRIMED, INC.

Global Unique Device Identification Database

00888867241909SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241275SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241268SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241152SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241145SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241138SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241114SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241107SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
10888867241401SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241251SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867329126SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241244SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241237SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241220SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
00888867241213SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)

Maude Adverse Events

EXTERNAL FIXATOR DEVICEUNK2014-09-15
X-WIREORTHOFIX INC.2007-06-18
UNKUNKUNK2007-06-07
X-WIRE 2X450MMORTHOFIX SRL2006-10-04
UNKUNKUNK2002-06-04
KLSEXTERNAL FIXATOR SCREWKLS MARTIN L.P.2001-01-22
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