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Theken Spine Llc

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered i recall (Z-0169-2011)Theken Spine Llc2010-11-01
Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the pl recall (Z-0087-2011)Theken Spine Llc2010-10-19
iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Numb recall (Z-1965-2009)Theken Spine LLC2009-09-03
Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc recall (Z-0272-2009)Theken Spine LLC2008-11-18
FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a recall (Z-2375-2008)Theken Spine LLC2008-09-18
Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicl recall (Z-0183-06)Theken Spine LLC2005-11-23

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