Company ยท US
Blackstone Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2010. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 16 |
| MNI | Orthosis, Spinal Pedicle Fixation | 10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 |
| MQP | Spinal Vertebral Body Replacement Device | 6 |
| HWX | Tap, Bone | 5 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| HRX | Arthroscope | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2010 | K093926 | FIREBIRD SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | NKB |
| May 4, 2010 | K100614 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES Blackstone Medical, Inc. | KWQ |
| Sep 25, 2009 | K092624 | FIREBIRD SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | NKB |
| Oct 17, 2008 | K082797 | BLACKSTONE PEDICLE SCREW SYSTEM Blackstone Medical, Inc. | NKB |
| Sep 15, 2008 | K081684 | BLACKSTONE PEDICLE SCREW SYSTEM Blackstone Medical, Inc. | NKB |
| Sep 4, 2008 | K082235 | BLACKSTONE PILLAR XL PEEK SPACERS Blackstone Medical, Inc. | MAX |
| Aug 28, 2008 | K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE Blackstone Medical, Inc. | OVD |
| Jul 23, 2008 | K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM Blackstone Medical, Inc. | MAX |
| Mar 13, 2008 | K080407 | BLACKSTONE SFS PARALLEL ROD CONNECTORS Blackstone Medical, Inc. | MNI |
| Mar 13, 2008 | K080394 | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM Blackstone Medical, Inc. | KWP |
| Feb 14, 2008 | K073420 | BLACKSTONE ASCENT MULTIAXIAL SCREWS Blackstone Medical, Inc. | KWP |
| Jan 24, 2008 | K073654 | BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR Blackstone Medical, Inc. | KWP |
| Jul 24, 2006 | K061229 | UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM Blackstone Medical, Inc. | KWQ |
| Feb 24, 2006 | K060350 | CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM Blackstone Medical, Inc. | MQP |
| Jun 14, 2005 | K051246 | CONSTRUX MINI PEEK VBR SYSTEM Blackstone Medical, Inc. | MQP |
| Jun 14, 2005 | K043548 | BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM Blackstone Medical, Inc. | KWQ |
| May 11, 2005 | K050892 | HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM Blackstone Medical, Inc. | KWQ |
| Feb 18, 2005 | K043338 | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM Blackstone Medical, Inc. | NQW |
| Oct 7, 2004 | K042514 | MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM Blackstone Medical, Inc. | MNI |
| Sep 20, 2004 | K042100 | BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR Blackstone Medical, Inc. | MNI |
| Aug 17, 2004 | K041939 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS Blackstone Medical, Inc. | MQP |
| Mar 31, 2004 | K033702 | BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM Blackstone Medical, Inc. | MQP |
| Mar 3, 2004 | K033980 | BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) Blackstone Medical, Inc. | KWP |
| Feb 11, 2004 | K040034 | BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER Blackstone Medical, Inc. | MNI |
| Oct 9, 2003 | K032700 | BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS Blackstone Medical, Inc. | MQP |
| Jun 27, 2003 | K030744 | BLACKSTONE SURGICAL TITANIUM MESH Blackstone Medical, Inc. | MQP |
| Jun 26, 2003 | K030581 | BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) Blackstone Medical, Inc. | MNH |
| Jun 12, 2003 | K030197 | BLACKSTONE POSTERIOR CERVICAL SYSTEM Blackstone Medical, Inc. | KWP |
| Apr 24, 2003 | K030595 | BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM Blackstone Medical, Inc. | KWQ |
| Apr 17, 2003 | K030862 | BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR Blackstone Medical, Inc. | MNI |
| Mar 28, 2003 | K022965 | BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE Blackstone Medical, Inc. | KWQ |
| Feb 21, 2003 | K030241 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | KWP |
| Nov 13, 2002 | K023498 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | KWP |
| Aug 21, 2002 | K022605 | BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER Blackstone Medical, Inc. | KWQ |
| Aug 6, 2002 | K022399 | BLACKSTONE SPINAL FIXATION SYSTEM SPACER Blackstone Medical, Inc. | KWQ |
| May 23, 2002 | K020620 | BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) Blackstone Medical, Inc. | KWQ |
| May 22, 2002 | K020600 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) Blackstone Medical, Inc. | KWQ |
| Apr 3, 2002 | K020674 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW Blackstone Medical, Inc. | MNH |
| Feb 1, 2002 | K013885 | BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS Blackstone Medical, Inc. | MNI |
| Jan 30, 2002 | K012184 | BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM Blackstone Medical, Inc. | KWQ |
| Jan 23, 2002 | K013558 | BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW Blackstone Medical, Inc. | KWQ |
| May 8, 2001 | K003735 | BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR Blackstone Medical, Inc. | MNI |
| Feb 28, 2000 | K994217 | BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | MNH |
| Jun 17, 1998 | K974885 | BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM Blackstone Medical, Inc. | KWQ |
| Sep 25, 1997 | K972768 | BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM Blackstone Medical, Inc. | HRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2010 | Blackstone Medical, Inc. Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070.
Non Sterile. Terminated |
KWQ | K050892 |
| May 19, 2010 | Blackstone Medical, Inc. 8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| May 19, 2010 | Blackstone Medical, Inc. 4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.
Intended to created a screw thread in a hole drilled into bone to facilitate placement Terminated |
HWX | None listed |
| Mar 16, 2010 | Blackstone Medical, Inc. Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA.
Intended to promote fusion of the cervical spin Terminated |
MNI | K030197 |
| Jul 6, 2009 | Blackstone Medical, Inc. Blackstone Medical:
ICON Modular Pedicle Screw System;
P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants. Terminated |
MNI | K042514 |
| Jan 26, 2008 | Blackstone Medical, Inc. Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Terminated |
KWQ | K050892 |
| Dec 11, 2007 | Blackstone Medical, Inc. Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm; Terminated |
MNI | None listed |
| Apr 19, 2006 | Blackstone Medical Inc. ICON Modular Spinal Fixation System used with the:
ICON Implant Case (containing Pedicle Screws) Item Number 54-1090
ICON Instrument Case 1 Item Number: 54-1091
ICON Instrument Case 2 Item Number: 54 Terminated |
KWQ | K042514 |