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Pioneer Surgical Technology, Inc.

United States·US-MF-000010369

Last updated September 17, 2026

Information

Country: United States
Address: 375, River Park Circle, Marquette, United States
Website: www.exalta.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 906-226-9909
PRRC Contact: Tim Kolesar
EUDAMED SRN: US-MF-000010369
FDA FEI Number: 1000115331
DUNS Number: —

Catalogue (8551)

Page 29 of 172

Device	Model / Reference	Registries	Class	Status
Cross-Fuse® II PEEK VBR/IBF System	38-FORK-18	FDA UDI	Class I	Unknown
Quantum BacFuse Spinous Process Fusion Plate	725-016	FDA UDI	Class I	Unknown
Songer® Spinal Cable System	400-655	FDA UDI	Class II	Unknown
Quantum Spinal Fixation System	10-475-FX-35	FDA UDI	Class II	Unknown
Bullet-Tip Peek Ibf System	32-10-32	FDA UDI	Class II	Unknown
Cross-Fuse® PEEK IBF System	35-DTRL14-15-6	FDA UDI	Class I	Unknown
Fusion Anterior Instrument Set	57-A-WEDGE	FDA UDI	Class I	Unknown
CervAlign Anterior Cervical Plate System	66-VST-40-12	FDA UDI	Class II	Unknown
Fortilink-L IBF System with TETRAfuse 3D Technology	65-L-2250-15	FDA UDI	Class II	Unknown
Unison™-C Anterior Cervical Fixation System	63-SCREWDRIVER	FDA UDI	Class II	Unknown
Slimfuse Anterior Cervical Plate System	21-346-D	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-081-03	FDA UDI	Class I	Active
Cross-Fuse® II PEEK VBR/IBF System	38-TRIAL-22-11-5C	FDA UDI	Class I	Unknown
CODA™ Anterior Cervical Plate System	58-102204068	FDA UDI	Class II	Active
Fusion™ Lateral Instrument Set	38-12PIT-4-S	FDA UDI	Class I	Unknown
CONTACT ALP Anterior Lumbar Plate System	25-SP-48	FDA UDI	Class II	Unknown
Fortilink-TS IBF System with TETRAfuse 3D Technology	65-TS-9-22	FDA UDI	Class II	Unknown
Quantum® BacFuse® Spinous Process Fusion Plate	83-RASP-14	FDA UDI	Class I	Unknown
MaxFuse VBR, 10 (D) x 12 (W) x 22 (H)	62-1012-33	FDA UDI	Class II	Unknown
Pac Plate™* Anterior Cervical Plate System	20-476-S	FDA UDI	Class II	Unknown
Streamline™* Tl Spinal Fixation System	01-PA-65-55	FDA UDI	Class II	Unknown
Streamline® TL Spinal Fixation System	01-PA-C-45-45	FDA UDI	Class II	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	26-3232-CLSD-11	FDA UDI	Class II	Unknown
Streamline Navigated Instruments	02-MODHANDLE-MDN	FDA UDI	Class II	Unknown
Unison™-C Anterior Cervical Fixation System	63-40-VSD-15	FDA UDI	Class II	Unknown
Quantum™* Spinal Fixation System	10-400-FX-20	FDA UDI	Class II	Unknown
Tritium® Sternal Cable Plate System	86-SCRCADDY-2	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-135-70	FDA UDI	Class II	Active
Unison®-C Anterior Cervical Fixation System	64-TR-2216-12-7L	FDA UDI	Class I	Unknown
Contact™* Ibf Peek Vbr/Ibf System	34-TRL30-12-12	FDA UDI	Class I	Unknown
CODA™ Anterior Cervical Plate System	58-102252018S	FDA UDI	Class II	Active
Fortilink-TS IBF System	65-TS-10-22-6L	FDA UDI	Class II	Unknown
Cross-Fuse PEEK IBF System	35-2250-13-6	FDA UDI	Class II	Unknown
Streamline®* Ct Cervico-Thoracic System	23-40-SWIV-26	FDA UDI	Class II	Unknown
Quantum™* Spinal Fixation System	10-400-FX-45	FDA UDI	Class II	Unknown
Streamline™* MIS Spinal Fixation System	05-PA-85-40	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-042-36	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-70SCREW-CDY	FDA UDI	Class I	Unknown
Streamline Navigated Instruments	04-CTAP-TT-55-MDN	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-FX-85-100	FDA UDI	Class II	Unknown
Aspect®* Anterior Cervical Plate System	27-354	FDA UDI	Class II	Unknown
AlloWedge	55-L-Tamp	FDA UDI	Class I	Unknown
Quantum™* Spinal Fixation System	10-575-PA-50	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-70-80	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-RS-85-85	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	724-621	FDA UDI	Class I	Unknown
Unison™-C Anterior Cervical Fixation System	63-35-VST-12	FDA UDI	Class II	Unknown
MIS FUSION™ Instruments	29-PUTTER	FDA UDI	Class I	Unknown
Slimfuse™* Anterior Cervical Plate System	21-FINALDRIV-TL	FDA UDI	Class I	Unknown
MaxFuse, VBR, 12 (D) x 14 (W) x 23 (H)	62-1517-34	FDA UDI	Class II	Unknown

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 11, 2014	Z-2076-2014	—	terminated	Lack of Sterility Assurance
Jun 14, 2013	Z-2616-2014	—	terminated	The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Sep 10, 2012	Z-2573-2014	—	terminated	Some set screw thread profiles were found not to be within specifications.
Oct 10, 2007	Z-0291-2008	—	terminated	The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
Mar 3, 2006	Z-0872-06	—	terminated	There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.
Jul 29, 2005	Z-0021-06	—	terminated	Screw may be incorrectly etched as to length.
Jul 29, 2005	Z-1457-05	—	terminated	The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.
Jul 29, 2005	Z-0020-06	—	terminated	Screw may be incorrectly etched as to length.
Jan 20, 2004	Z-0561-04	—	terminated	Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
May 28, 2003	Z-0948-03	—	terminated	Label may bear an incorrect part number [2227-02-02] and size [03.8MM].