Pioneer Surgical Technology, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1833824	1000115331	Pioneer Surgical Technology, Inc.	1	N	2026-01-01	375 RIVER PARK CIRCLE Marquette MI US 49855

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00846468049430	nanOss ABGS - Advanced Bone Graft Substitute 1cc	+1(906)226-9909	regulatory@exalta.com
00846468049447	nanOss ABGS - Advanced Bone Graft Substitute 2cc	+1(906)226-9909	regulatory@exalta.com
00846468049454	nanOss ABGS - Advanced Bone Graft Substitute 5cc	+1(906)226-9909	regulatory@exalta.com
00846468049461	nanOss ABGS - Bone Void Filler 10cc	+1(906)226-9909	regulatory@exalta.com
00846468049478	nanOss ABGS - Bone Void Filler 20cc	+1(906)226-9909	regulatory@exalta.com
00846468049515	nanOss Loaded ABGS - Bone Void Filler 5cc	+1(906)226-9909	regulatory@exalta.com
00846468049522	nanOss Loaded ABGS - Bone Void Filler 10cc	+1(906)226-9909	regulatory@exalta.com
00846468049546	nanOss 3D ABGS - Bone Void Filler 5cc	+1(906)226-9909	regulatory@exalta.com

exalta.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
302173	1825745041	K992617	HEX BUTTON	HTN	1999-10-27
302173	1563032903	K992616	SDB CERCLAGE SYSTEM	JDQ	1999-10-27
302173	1862539439	K941213	SONGER CABLE SYSTEM	JDQ	1994-04-19
302173	1608103850	K261271	Cable-Ready® Cable Grip System	JDQ	2026-07-16
302173	1896562569	K230993	CODA™ Anterior Cervical Plate System	KWQ	2023-06-20
302173	1541755836	K222493	CODA™ Anterior Cervical Plate System	KWQ	2022-11-18
302173	1112521951	K220244	DVR® Crosslock Wrist Spanning Plate (131849181)	HRS	2022-04-28
302173	1246438378	K201497	EVOS Cabling System	JDQ	2020-10-28
302173	1222630150	K151907	Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables	KTT	2015-12-30
302173	1814613748	K151848	Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System	JDQ	2016-01-15
302173	1461645689	K151716	Cable-Ready Cable Grip System: Cable-Ready Bone Plate System	HRS	2016-01-28
302173	1042152091	K003496	CANNULATED SCREW SYSTEM	HTN	2001-02-08
302173	1277242358	K002110	SPL CRIMP SYSTEM	JDQ	2000-10-06
302173	1120641528	K001709	TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067	JDQ	2000-08-31
302173	1514350178	K000734	PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601	KTT	2000-05-05
302173	1019117243
302173	1028379479
302173	1038049278
302173	1074854629
302173	1117534265
302173	1117794825
302173	1125457373
302173	1132257617
302173	1168080807
302173	1174395350
302173	1180669888
302173	1197793944
302173	1216600054
302173	1227759461
302173	1252558916
302173	1294053782
302173	1298784425
302173	1310226416
302173	1327259055
302173	1337161639
302173	1338326151
302173	1343486760
302173	1346994873
302173	1403612297
302173	1419086697
302173	1442506840
302173	1456875915
302173	1543001651
302173	1558444067
302173	1576833651
302173	1618197183
302173	1658803542
302173	1689955316
302173	1708418566
302173	1719963413
302173	1738333649
302173	1766539028
302173	1789794872
302173	1834293144
302173	1850110350
302173	1852348619
302173	1856631673
302173	1873789763
302173	1908896171
302173	1919680944
302173	1925714913
302173	1936389664
302173	1947772907
302173	1960041473
302173	2039403156
302173	2051564149
302173	2053436764

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JDQ	7	2026-07-16
KWQ	2	2023-06-20
HRS	2	2022-04-28
KTT	2	2015-12-30
HTN	2	2001-02-08

PMN#

CervAlign® Anterior Cervical Plate System
2021-06-23
Pioneer Surgical Technology, Inc.
Streamline MIS Spinal Fixation System
2019-11-26
Pioneer Surgical Technology, Inc.
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
2013-06-05
PIONEER SURGICAL TECHNOLOGY, INC.
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
2012-03-12
PIONEER SURGICAL TECHNOLOGY, INC.
NB3D BONE VOID FILLER
2011-11-22
PIONEER SURGICAL TECHNOLOGY, INC.
PIONEER CROSSFUSE II IBF/VBR SYSTEM
2011-09-28
PIONEER SURGICAL TECHNOLOGY, INC.
STREAMLINE TL SPINAL SYSTEM
2011-05-12
PIONEER SURGICAL TECHNOLOGY, INC.
PIONEER CANNULATED SCREW SYSTEM
2010-10-20
PIONEER SURGICAL TECHNOLOGY, INC.

GUDID#

nanOss ABGS - Advanced Bone Graft Substitute 1cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss ABGS - Advanced Bone Graft Substitute 2cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss ABGS - Advanced Bone Graft Substitute 5cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss ABGS - Bone Void Filler 10cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss ABGS - Bone Void Filler 20cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss Loaded ABGS - Bone Void Filler 5cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss Loaded ABGS - Bone Void Filler 10cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss 3D ABGS - Bone Void Filler 5cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss 3D ABGS - Bone Void Filler 10cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss 3D ABGS - Bone Void Filler 10cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss 3D ABGS - Bone Void Filler 20cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss Loaded ABGS - Advanced Bone Graft Substitute Kit - 5cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss BA - Loaded - Advanced Bone Graft Substitute Kit - 10cc
Pioneer Surgical Technology, Inc.
2015-12-14
nanOss® 3D Plus™ - resorbable porous calcium phosphate bone void filler 25 x 50 x 4mm; 5 cc
Pioneer Surgical Technology, Inc.
2018-09-19
nanOss® 3D Plus™ - resorbable porous calcium phosphate bone void filler 25 x 50 x 8mm; 10 cc
Pioneer Surgical Technology, Inc.
2018-09-19
nanOss® 3D Plus™ - resorbable porous calcium phosphate bone void filler 25 x 100 x 8mm; 20 cc
Pioneer Surgical Technology, Inc.
2018-09-19
nanOss® 3D Plus™ - resorbable porous calcium phosphate bone void filler 25 x 100 x 4mm; 10cc
Pioneer Surgical Technology, Inc.
2018-09-19
CODA™ Anterior Cervical Plate System - Modular Drill
Pioneer Surgical Technology, Inc.
2023-06-28
CODA™ Anterior Cervical Plate System - Modular Drill
Pioneer Surgical Technology, Inc.
2023-06-28
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 1 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 2 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 3 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 3 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26
CODA™ Anterior Cervical Plate System - 3 Level Plate
Pioneer Surgical Technology, Inc.
2023-06-26

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