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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 20 of 172

Device	Model / Reference	Registries	Class	Status
MIS FUSION™ Instruments	29-9PIT-4-D	FDA UDI	Class I	Unknown
Bullet-Tip Peek Vbr/Ibf System	32-TRL13-22-6L	FDA UDI	Class I	Unknown
PAC Plate® Anterior Cervical Plate System	20-SCREWCADDY	FDA UDI	Class I	Unknown
Fortilink-L IBF System	65-L-2245-11	FDA UDI	Class II	Unknown
Unison®-C Anterior Cervical Fixation System	64-1814-10-7L	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-045-70	FDA UDI	Class II	Active
Cross-Fuse® II PEEK VBR/IBF System	38-2250-13-18L	FDA UDI	Class II	Unknown
Release® Laminoplasty Fixation System	28-ST-20-12	FDA UDI	Class II	Unknown
Clarity ® Retractor System	53-W-BL-100-42	FDA UDI	Class I	Unknown
Quantum Spinal Fixation System	10-575-PA-60	FDA UDI	Class II	Unknown
Quantum Spinal Fixation System	10-INSERTER	FDA UDI	Class I	Unknown
Slimfuse™* Anterior Cervical Plate System	21-122-S	FDA UDI	Class II	Unknown
Pac Plate™* Anterior Cervical Plate System	20-40-FST-18	FDA UDI	Class II	Unknown
Cequence	0201-0024	FDA UDI	Class II	Unknown
Cross-Fuse™* Ii Peek Vbr/Ibf System	38-1850-9-6L	FDA UDI	Class II	Unknown
Cross-Fuse™* Ii Peek Vbr/Ibf System	38-1445-15-6L	FDA UDI	Class II	Unknown
Fortilink-L IBF System with TETRAfuse 3D Technology	65-L-2255-13-12L	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-030-70	FDA UDI	Class II	Active
Streamline® TL Spinal Fixation System	01-PA-C-65-70	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-018-41	FDA UDI	Class II	Active
Zimmer® Cannulated Screw System	00-1147-110-65	FDA UDI	Class II	Active
Zimmer® Cannulated Screw System	00-1147-018-31	FDA UDI	Class II	Active
Zimmer® Cannulated Screw System	00-1147-050-72	FDA UDI	Class II	Active
CODA™ Anterior Cervical Plate System	58-202202032	FDA UDI	Class I	Active
CODA™ Anterior Cervical Plate System	58-102252011S	FDA UDI	Class II	Active
Cross-Fuse® II PEEK VBR/IBF System	38-TRIAL-14-9-5C	FDA UDI	Class I	Unknown
Fusion™ Lateral Instrument Set	35-SHAVER-16	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-PA-75-25	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-060-41	FDA UDI	Class II	Active
MaxFuse PEEK VBR SYSTEM	724-835	FDA UDI	Class I	Unknown
CervAlign Anterior Cervical Plate System	66-VST-40-16	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-075-77	FDA UDI	Class II	Active
Cross-Fuse™* Ii Peek Vbr/Ibf System	38-1435-7	FDA UDI	Class II	Unknown
Screw, Cann., 7.0mmx90mm, 24mm Thread	431-694-090	FDA UDI	Class II	Unknown
Pac Plate™* Anterior Cervical Plate System	20-40-VST-20	FDA UDI	Class II	Unknown
Streamline™* Tl Spinal Fixation System	01-PA-55-30	FDA UDI	Class II	Unknown
Streamline® MIS Spinal Fixation System	51-GW-400-SHARP-SS	FDA UDI	Class II	Unknown
T-Plus™* Peek Vbr/Ibf System	30-T-1027-11	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-030-41	FDA UDI	Class II	Active
Bigfoot® ALIF	90-BIGFT-TRL-20	FDA UDI	Class I	Unknown
Contact™* Ibf Peek Vbr/Ibf System	34-A36-18-12	FDA UDI	Class II	Unknown
Streamline®* Ct Cervico-Thoracic System	23-40-SWIV-28	FDA UDI	Class II	Unknown
Quantum™* Spinal Fixation System	10-675-PA-25	FDA UDI	Class II	Unknown
MIS FUSION™ Instruments	29-BALLPROBE	FDA UDI	Class I	Unknown
DePuy Songer Spinal Cable System	400-106	FDA UDI	Class II	Unknown
T-Plus PEEK IBF System	30-T-15-6	FDA UDI	Class II	Unknown
Fortilink-L IBF System with TETRAfuse 3D Technology	65-L-1855-9-6L	FDA UDI	Class II	Unknown
Bullet-Tip Peek Ibf System	32-11-26	FDA UDI	Class II	Unknown
CervAlign Anterior Cervical Plate System	66-FST-45-16	FDA UDI	Class II	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	23-35-PA-42	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].