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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 2 of 172

Device	Model / Reference	Registries	Class	Status
Cross-Fuse™* Ii Peek Vbr/Ibf System	38-1850-15-6L	FDA UDI	Class II	Unknown
C-Plus™* Peek Vbr/Ibf System	30-C-1214-9	FDA UDI	Class II	Unknown
Quantum™* Spinal Fixation System	10-PJC5003080-R	FDA UDI	Class II	Unknown
Lat-Fuse™* Lateral Plate System	38-SD55-36	FDA UDI	Class II	Unknown
Clarity® Lateral Retractor System	38-PIN-100	FDA UDI	Class I	Unknown
Bullet-Tip Peek Ibf System	32-10-22-6L	FDA UDI	Class II	Unknown
CervAlign Anterior Cervical Plate System	66-VST-45-16	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	724-298	FDA UDI	Class I	Unknown
Fusion™ Posterior Instrument Set	30-BOXCHISEL-8	FDA UDI	Class I	Unknown
Lat-Fuse™* Lateral Plate System	38-SD65-40	FDA UDI	Class II	Unknown
Fusion™ Posterior Instrument Set	30-SHAVER-10	FDA UDI	Class I	Unknown
Release® Laminoplasty Fixation System	28-CADDY-PLATE-STD	FDA UDI	Class II	Unknown
C-Plus™* Peek Vbr/Ibf System	30-C-1214-11	FDA UDI	Class II	Unknown
T-Plus™* Peek Vbr/Ibf System	30-T-8-6	FDA UDI	Class II	Unknown
Fusion Anterior Instrument Set	57-A-SPREADER	FDA UDI	Class I	Unknown
Streamline® TL Spinal Fixation System	01-PA-C-65-55	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-052-30	FDA UDI	Class II	Active
CODA™ Anterior Cervical Plate System	58-102204084	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	723-219	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-PA-875-55	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-140-65	FDA UDI	Class II	Active
Cross-Fuse™* Ii Peek Vbr/Ibf System	38-2250-15-12L	FDA UDI	Class II	Unknown
CODA™ Anterior Cervical Plate System	58-102203039	FDA UDI	Class II	Active
Tritium® Sternal Cable Plate System	86-30-08-4	FDA UDI	Class II	Unknown
Streamline™* Tl Spinal Fixation System	01-FX-55-50	FDA UDI	Class II	Unknown
Streamline™* Tl Spinal Fixation System	01-PA-75-95	FDA UDI	Class II	Unknown
Fortilink-L IBF System with TETRAfuse 3D Technology	65-L-1445-13-6L	FDA UDI	Class II	Unknown
Quantum Spinal Fixation System	10-TAP-525	FDA UDI	Class I	Unknown
Aspect®* Anterior Cervical Plate System	27-226	FDA UDI	Class II	Unknown
Cequence Anterior Cervical Plate	0255-0010	FDA UDI	Class II	Unknown
Cequence	0207-4018	FDA UDI	Class II	Unknown
Aspect®* Anterior Cervical Plate System	27-363	FDA UDI	Class II	Unknown
Streamline® TL Spinal Fixation System	01-PA-C-65-75	FDA UDI	Class II	Unknown
Bullet-Tip Peek Vbr/Ibf System	32-CADDY-22-2	FDA UDI	Class I	Unknown
Streamline® TL Spinal Fixation System	01-PA-C-65-100	FDA UDI	Class II	Unknown
Bullet-Tip Peek Vbr/Ibf System	32-TRL15-22-6L	FDA UDI	Class I	Unknown
Aspect®* Anterior Cervical Plate System	27-112	FDA UDI	Class II	Unknown
Sternal Cable System	401-096	FDA UDI	Class II	Unknown
Quantum Spinal Fixation System	10-875-FX-45	FDA UDI	Class II	Unknown
Streamline™* MIS Spinal Fixation System	05-PA-85-35	FDA UDI	Class II	Unknown
Streamline Navigated Instruments	04-CTAP-TT-65L-MDN	FDA UDI	Class II	Unknown
Unison™-C Anterior Cervical Fixation System	63-40-FST-15	FDA UDI	Class II	Unknown
Zimmer® Cannulated Screw System	00-1147-046-46	FDA UDI	Class II	Active
Cross-Fuse PEEK IBF System	35-DTRL14-15	FDA UDI	Class I	Unknown
Fortilink-TS IBF System with TETRAfuse 3D Technology	65-TS-17-22-6L	FDA UDI	Class II	Unknown
Unison®-C Anterior Cervical Fixation System	64-34-SD-12	FDA UDI	Class II	Unknown
C-Plus PEEK VBR/IBF System	725-060	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	723-858	FDA UDI	Class I	Unknown
AlloWedge	55-MALLET	FDA UDI	Class I	Unknown
Streamline® OCT Occipito-Cervico-Thoracic System	26-DEPTH-GAGE	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].