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Synthes Spine

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in recall (Z-1348-2009)Synthes Spine2009-06-10
Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes R recall (Z-1248-2009)Synthes Spine2009-06-01
Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes recall (Z-1249-2009)Synthes Spine2009-06-01
Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjuncti recall (Z-1324-2009)Synthes Spine2009-05-29
In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes' Rapid R recall (Z-1640-2009)Synthes Spine2009-05-21
In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. Used with Synthes' Rapi recall (Z-1641-2009)Synthes Spine2009-05-21
NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery recall (Z-0963-2009)Synthes Spine2009-02-03
NFix II System 200 mm, Catalog number NX60200-1. spinal fusion surgery recall (Z-0964-2009)Synthes Spine2009-02-03
N-Hance System 150 mm, Catalog number NH60150-1. spinal fusion surgery recall (Z-0965-2009)Synthes Spine2009-02-03
TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery recall (Z-0966-2009)Synthes Spine2009-02-03
NFlex Stabilization System 200 mm, Catalog number NF60020-1. spinal fusion surgery recall (Z-0967-2009)Synthes Spine2009-02-03
NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery recall (Z-0968-2009)Synthes Spine2009-02-03
Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The recall (Z-0931-2009)Synthes Spine2009-01-30

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