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Blackstone Medical, Inc.

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System recall (Z-1653-2010)Blackstone Medical, Inc.2010-05-26
4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive recall (Z-1611-2010)Blackstone Medical, Inc.2010-05-19
5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive recall (Z-1612-2010)Blackstone Medical, Inc.2010-05-19
6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive recall (Z-1613-2010)Blackstone Medical, Inc.2010-05-19
7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive recall (Z-1614-2010)Blackstone Medical, Inc.2010-05-19
8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive recall (Z-1615-2010)Blackstone Medical, Inc.2010-05-19
Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, recall (Z-1144-2010)Blackstone Medical, Inc.2010-03-16
Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-902 recall (Z-1655-2009)Blackstone Medical, Inc.2009-07-06
Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-31 recall (Z-0478-2008)Blackstone Medical, Inc.2008-01-26
Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series recall (Z-0363-2008)Blackstone Medical, Inc.2007-12-11
ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle S recall (Z-0716-06)Blackstone Medical Inc.2006-04-19

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