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SeaSpine Inc

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument recall (Z-1841-2014)SeaSpine Inc2014-06-20
Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 Malibu Spinal System when used as a recall (Z-1918-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when used as a recall (Z-1919-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540 Malibu Spinal System when used as a recall (Z-1920-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545 Malibu Spinal System when used as a recall (Z-1921-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 Malibu Spinal System when used as a recall (Z-1922-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 Malibu Spinal System when used as a recall (Z-1923-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570 Malibu Spinal System when used as a recall (Z-1924-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540 Malibu Spinal System when recall (Z-1925-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545 Malibu Spinal System when recall (Z-1926-2009)SeaSpine, Inc2009-09-03
Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550 Malibu Spinal System when recall (Z-1927-2009)SeaSpine, Inc2009-09-03

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Every clearance here is in the API, with alerts when new ones post.