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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 13 of 172

Device	Model / Reference	Registries	Class	Status
Cross-Fuse™* Peek Vbr/Ibf System	35-1455-13	FDA UDI	Class II	Unknown
Contact PEEK IBF System	34-TRL36-16-12	FDA UDI	Class I	Unknown
Quantum™* Mis Cannulated System	51-575-FX-45	FDA UDI	Class II	Unknown
Quantum® Spinal Fixation System	10-YOKEFORK	FDA UDI	Class I	Unknown
Streamline™* Tl Spinal Fixation System	01-PA-55-35	FDA UDI	Class II	Unknown
Contact PEEK IBF System	34-WINDOW36-16	FDA UDI	Class I	Unknown
Quantum Spinal Fixation System	10-FINALDRIVER	FDA UDI	Class I	Unknown
Cequence	0211-0016	FDA UDI	Class II	Unknown
Unison™-C Anterior Cervical Fixation System	63-1412-9-7L	FDA UDI	Class II	Unknown
Quantum Spinal Fixation System	10-PJC5003070-R	FDA UDI	Class II	Unknown
MIS FUSION™ Instruments	29-MCUR-0-RA	FDA UDI	Class I	Unknown
Aspect®* Anterior Cervical Plate System	27-230	FDA UDI	Class II	Unknown
Cross-Fuse® II PEEK VBR/IBF System	38-1855-17-18L	FDA UDI	Class II	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	26-OCPS-525-14	FDA UDI	Class II	Unknown
T-Plus™ PEEK VBR/IBF System	30-T-TRL-13-6	FDA UDI	Class I	Unknown
Streamline™* MIS Spinal Fixation System	04-55-RR-55	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-150-70	FDA UDI	Class II	Active
Streamline® TL Spinal Fixation System	02-LID-LSC-65	FDA UDI	Class I	Unknown
Bullet-Tip Peek Vbr/Ibf System	32-17-26-6L	FDA UDI	Class II	Unknown
Streamline™* MIS Spinal Fixation System	05-PA-65-40	FDA UDI	Class II	Unknown
Screw, Cannulated, 7.5x165mm, 75mm Thread	419-876-165	FDA UDI	Class II	Unknown
Cross-Fuse PEEK IBF System	35-1850-17-6	FDA UDI	Class II	Unknown
PAC Plate® Anterior Cervical Plate System	20-PAC-SYSTEM	FDA UDI	Class I	Unknown
Bullet-Tip Peek Ibf System	33-SPREAD17	FDA UDI	Class I	Unknown
Streamline® TL Spinal Fixation System	01-PA-C-95-60	FDA UDI	Class II	Unknown
Clarity® Lateral Retractor System	38-180-C-BLD-CADDY	FDA UDI	Class I	Unknown
Slimfuse™* Anterior Cervical Plate System	21-126-D	FDA UDI	Class II	Unknown
Fusion™ Posterior Instrument Set	30-RASP-A	FDA UDI	Class I	Unknown
Clarity® Lateral Retractor System	38-DILATOR-16-E	FDA UDI	Class I	Unknown
CODA™ Anterior Cervical Plate System	58-202281051	FDA UDI	Class I	Active
Fusion™ Posterior Instrument Set	30-SHAVER2-7	FDA UDI	Class I	Unknown
CODA™ Anterior Cervical Plate System	58-202201022	FDA UDI	Class I	Active
T-Plus™ PEEK VBR/IBF System	30-T-TRL-9-6	FDA UDI	Class I	Unknown
CervAlign Anterior Cervical Plate System	66-FST-45-18	FDA UDI	Class II	Unknown
T-Plus PEEK IBF System	30-T-TRL-7-S	FDA UDI	Class I	Unknown
Quantum Spinal Fixation System	10-INSTCASE-TL	FDA UDI	Class I	Unknown
Cross-Fuse™* Peek Vbr/Ibf System	35-1855-17	FDA UDI	Class II	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	26-COMPRESSOR	FDA UDI	Class I	Unknown
Cross-Fuse™* Ii Peek Vbr/Ibf System	38-2650-15	FDA UDI	Class II	Unknown
Streamline® TL Spinal Fixation System	01-PA-C-55-50	FDA UDI	Class II	Unknown
Cross-Fuse® II PEEK VBR/IBF System	38-2660-15-12L	FDA UDI	Class II	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	26-OCPCOUNTER-T	FDA UDI	Class I	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	26-FTAP-30-16	FDA UDI	Class I	Unknown
Lat-Fuse™* Lateral Plate System	38-SD60-48	FDA UDI	Class II	Unknown
Clarity® Lateral Retractor System	38-180-C-BLADE-140	FDA UDI	Class I	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	26-3255-CLSD-11	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-024-00	FDA UDI	Class I	Active
Fortilink-TS IBF System with TETRAfuse 3D Technology	65-TS-8-26-6L	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-065-70	FDA UDI	Class II	Active
Clarity ® Retractor System	53-BLADEPULL	FDA UDI	Class I	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].