Pioneer Surgical Technology, Inc.
Pioneer Surgical Technology, Inc. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2026, with 3 FDA device recalls on record.
Top product codes for Pioneer Surgical Technology, Inc.
FDA recalls by Pioneer Surgical Technology, Inc.
- Z-2076-2014 — Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
- Z-2616-2014 — Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
- Z-2573-2014 — STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Pioneer Surgical Technology, Inc.
- K261271 — Cable-Ready® Cable Grip System
- K251436 — Resolve Anterior Cervical Plate System
- K222493 — CODA Anterior Cervical Plate System
- K211408 — CervAlign® Anterior Cervical Plate System
- K192396 — Streamline MIS Spinal Fixation System
- K140696 — STREAMLINE TL SPINAL FIXATION SYSTEM
- K133455 — CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
- K133623 — C-PLUS
- K132050 — NB3D BONE VOID FILLER
- K133785 — TRITIUM STERNAL CABLE PLATE SYSTEM
- K131724 — PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
- K131100 — STREAMLINE TL SPINAL SYSTEM
- K130427 — PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
- K130286 — STREAMLINE MIS SPINAL FIXATION SYSTEM
- K121725 — PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
- K122293 — PIONEER STERNAL CABLE PLATE SYSTEM
- K120016 — PIONEER STERNAL ASSIST IMPLANT SYSTEM
- K120724 — PIONEER LATERAL PLATE SYSTEM
- K112757 — PIONEER POSTERIOR CERVICO THORACIC SYSTEM
- K113218 — PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
- K111944 — NB3D BONE VOID FILLER
- K112496 — PIONEER CROSSFUSE II IBF/VBR SYSTEM
- K111528 — PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
- K111502 — STREAMLINE TL SPINAL SYSTEM
- K110692 — STREAMLINE TL SPINAL SYSTEM
- K110367 — PIONEER SPINAL PROCESS FUSION PLATE
- K102903 — PIONEER CANNULATED SCREW SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.