BIOPRO, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1833506	1832656	BIOPRO, INC.	1	Y	2026-01-01	2929 Lapeer Rd PORT HURON MI US 48060

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
43022	1188624785	K992144	BIOPRO RIMMED ACETABULAR COMPOMENT	LZO	1999-09-22
43022	1273069598	K990821	PROVIDENCE CUP SYSTEM	JDI	1999-04-29
43022	2072709072	K964472	RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT	KYI	1997-02-03
43022	1280267259	K963433	THREADED FIXATION PIN	JDW	1996-11-06
43022	2072542416	K961157	WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW	HWC	1996-05-17
43022	1622750537	K955916	TOWNLEY TOTAL ELBOW SYSTEM	JDC	1996-08-08
43022	1058679790	K954768	BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD	LZO	1996-01-18
43022	1685147489	K953045	BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD	LZO	1995-09-27
43022	2043997682	K925682	BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED	LZO	1994-01-07
43022	1472066423	K922841	BIOPRO MODULAR TIBIAL TRAY	JWH	1993-09-21
43022	1293672202	K922500	PSL TOTAL HIP REPLACEMENT SYSTEM	LPH	1994-01-07
43022	1539917095	K912641	BIOPRO ZIRALLOY MODULAR FEMORAL HEADS	LZO	1991-11-27
43022	1281399103	K904448	TOWNLEY TOTAL KNEE (TTK)	JWH	1991-07-17
43022	1629004734	K895886	BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM	KWL	1989-12-01
43022	1666185540	K890044	BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE	HRY	1989-11-06
43022	1876699180	K882869	TOWNLEY COX COMB ACETABULAR COMPONENT	JDI	1988-10-14
43022	1786424549	K872856	BIOPRO 32MM BALL	JDI	1987-08-17
43022	1650900143	K242121	mBôs (Monogram mBôs TKA System)	OLO	2025-03-14
43022	1290239141	K191297	iNSitu Bipolar Hip System	KWY	2019-09-17
43022	1551918146	K173013	WishBone K-Wire System	HTY	2017-12-14
43022	1590266335	K163627	Shotel Ankle Arthrodesis Nail System	HSB	2017-09-14
43022	1828396694	K162674	BioPro Foot Plating Systems	HRS	2017-06-16
43022	1867787099	K150693	PHIN-FX Cannulated Lag Screw System	HWC	2015-10-13
43022	1511289401	K132510	BIOPRO - INFINITY PLATE ANCHOR SYSTEM	HTN	2013-10-24
43022	1749974176	K130298	BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM	JDW	2013-06-18
43022	1469088060	K121973	BIOPRO HEMI-EDGE TOE SYSTEM	KWD	2012-10-30
43022	1257585436	K101030	MODIFICATION TO HBS HEADLESS BONE SCREW	HWC	2010-06-03
43022	2055402844	K100761	BIOPRO POLAR HEAD	KWY	2010-12-03
43022	1586936916	K090208	BIOPRO FEMORAL HEADS	JDI	2009-05-22
43022	1243062120	K083490	BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685	HTY	2009-03-18
43022	1739809349	K082468	APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)	KWY	2009-02-18
43022	1896398679	K081149	BIOPRO GO-EZ SCREW	HWC	2008-08-05
43022	1823898906	K072298	BIOPRO MEMORY STAPLE, MODELS 18062-18073	JDR	2007-10-29
43022	1229441692	K061798	BIOPRO MEMORY STAPLE	JDR	2006-08-21
43022	1999860274	K061089	MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599	KYI	2006-06-20
43022	1455432178	K052596	MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507	KYI	2005-11-15
43022	1925833229	K043542	BIOPRO TARA FEMORAL RESURFACING COMPONENT	KXA	2005-05-18
43022	1147169025	K041936	BIOPRO SUBTALAR IMPLANT	HWC	2004-09-08
43022	1882279921	K041595	TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870	KWD	2004-11-12
43022	1689491884	K020791	HBS HEADLESS BONE SCREW	HWC	2002-06-06
43022	1723741567	K001046	BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS	KWS	2000-06-08
43022	1062041697
43022	1401045213
43022	1633647713
43022	1645239965
43022	1675429889
43022	1925907189
43022	1029127456
43022	1053881230
43022	1057774673
43022	1083525947
43022	1110388303
43022	1111440730
43022	1156520663
43022	1175609658
43022	1188291661
43022	1189150555
43022	1209039671
43022	1209846081
43022	1234555010
43022	1290239141
43022	1310469253
43022	1313184071
43022	1390755738
43022	1405139652
43022	1421759396
43022	1440514655
43022	1441069409
43022	1453826680
43022	1464897798
43022	1476504087
43022	1507272858
43022	1535878178
43022	1544561291
43022	1553295616
43022	1565699876
43022	1568756438
43022	1573442024
43022	1591181371
43022	1622982941
43022	1647836940
43022	1701056664
43022	1707810849
43022	1731213821
43022	1734739408
43022	1739769418
43022	1742641510
43022	1753023647
43022	1753813378
43022	1756704575
43022	1818889724
43022	1954990817
43022	1991429993
43022	2036449534
43022	2054392415

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HWC	6	2015-10-13
LZO	5	1999-09-22
JDI	4	2009-05-22
KWY	3	2019-09-17
KYI	3	2006-06-20
HTY	2	2017-12-14
JDW	2	2013-06-18
KWD	2	2012-10-30
JDR	2	2007-10-29
LPH	2	1994-01-07
JWH	2	1993-09-21
OLO	1	2025-03-14
HSB	1	2017-09-14
HRS	1	2017-06-16
HTN	1	2013-10-24
KXA	1	2005-05-18
KWS	1	2000-06-08
JDC	1	1996-08-08
KWL	1	1989-12-01
HRY	1	1989-11-06

PMN#

Shotel Ankle Arthrodesis Nail System
2017-09-14
BioPro, Inc.
BioPro Foot Plating Systems
2017-06-16
BIOPRO, INC.
BIOPRO - INFINITY PLATE ANCHOR SYSTEM
2013-10-24
BIOPRO, INC.
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
2013-06-18
BIOPRO, INC.
BIOPRO HEMI-EDGE TOE SYSTEM
2012-10-30
BIOPRO, INC.
BIOPRO POLAR HEAD
2010-12-03
BIOPRO, INC.
MODIFICATION TO HBS HEADLESS BONE SCREW
2010-06-03
BIOPRO, INC.
BIOPRO FEMORAL HEADS
2009-05-22
BIOPRO, INC.
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
2009-03-18
BIOPRO, INC.
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
2008-12-15
BIOPRO, INC.
BIOPRO GO-EZ SCREW
2008-08-05
BIOPRO, INC.
BIOPRO MEMORY STAPLE, MODELS 18062-18073
2007-10-29
BIOPRO, INC.
BIOPRO MEMORY STAPLE
2006-08-21
BIOPRO, INC.
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
2006-06-20
BIOPRO, INC.
MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
2005-11-15
BIOPRO, INC.
BIOPRO TARA FEMORAL RESURFACING COMPONENT
2005-05-18
BIOPRO, INC.
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
2004-11-12
BIOPRO, INC.
BIOPRO SUBTALAR IMPLANT
2004-09-08
BIOPRO, INC.
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
2000-06-08
BIOPRO, INC.
PROVIDENCE CUP SYSTEM
1999-04-29
BIOPRO, INC.
POWDER FREE LATEX EXAMINATION GLOVE
1996-05-24
BIOPRO, INC.
PSL TOTAL HIP REPLACEMENT SYSTEM
1994-01-07
BIOPRO, INC.
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIED
1994-01-07
BIOPRO, INC.
BIOPRO MODULAR TIBIAL TRAY
1993-09-21
BIOPRO, INC.
BIOPRO DRG CUSTOM HIP REPLACEMENT SYSTEM
1992-10-15
BIOPRO, INC.
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
1991-11-27
BIOPRO, INC.
TOWNLEY GREAT TOE JOINT
1991-11-22
BIOPRO, INC.
TOWNLEY TOTAL KNEE (TTK)
1991-07-17
BIOPRO, INC.
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP
1991-06-13
BIOPRO, INC.
BIOPRO TRINITY ACETABULAR CUP
1991-01-04
BIOPRO, INC.
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
1989-12-01
BIOPRO, INC.
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
1989-11-17
BIOPRO, INC.
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
1989-11-06
BIOPRO, INC.
TOWNLEY COX COMB ACETABULAR COMPONENT
1988-10-14
BIOPRO, INC.
BIOPRO PC FEMORAL HIP COMPONENT
1988-08-29
BIOPRO, INC.
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
1987-12-14
BIOPRO, INC.
BIOPRO FEMORAL HIP COMPONENT
1987-08-26
BIOPRO, INC.
BIOPRO 32MM BALL
1987-08-17
BIOPRO, INC.

GUDID#

ACCU-CUT™ TWO STAGE - 16957
BIOPRO, INC.
2015-09-16
ACCU-CUT™ TWO STAGE S - 16958
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 3mm OFFSET - 17300
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 3mm OFFSET S - 17306
BIOPRO, INC.
2015-09-16
ACCU-CUT™ STANDARD W/2 BLADES - 17502
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 1mm OFFSET W/2 BLADES - 17503
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 2mm OFFSET W/2 BLADES - 17504
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 3mm OFFSET W/2 BLADES - 17505
BIOPRO, INC.
2015-09-16
ACCU-CUT™ TWO STAGE W/2 BLADES - 17506
BIOPRO, INC.
2015-09-16
ACCU-CUT™ STD MICRO CHOICE - 17721
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 1 mm MICRO CHOICE - 17733
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 2 mm MICRO CHOICE - 17734
BIOPRO, INC.
2015-09-16
ACCU-CUT™ TWO STAGE MICRO - 17735
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 2mm W/THREADED K-WIRES - 18578
BIOPRO, INC.
2015-09-16
ACCU-CUT™ STANDARD - 19505
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 1MM - 19506
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 2MM - 19507
BIOPRO, INC.
2015-09-16
ACCU-CUT™ 3MM - 19508
BIOPRO, INC.
2015-09-16
ACCU-CUT™ TWO STAGE - 19509
BIOPRO, INC.
2015-09-16
ACCU-CUT™ LONG ARM - 19510
BIOPRO, INC.
2015-09-16
ACCU-CUT™ Z GUIDE - 19511
BIOPRO, INC.
2015-09-16
ACCU-CUT™ TWO STAGE SYNTHESE - 19536
BIOPRO, INC.
2015-09-16
ACCU-CUT™ DMAA - 19720
BIOPRO, INC.
2015-09-16
ACCUCUT GUIDE DMAA RIGHT PKG - 19721
BIOPRO, INC.
2015-09-16
2.5 x 19mm HBS Screw - 19554
BIOPRO, INC.
2021-06-14
Horizon Subtalar Gen 2 - 11mm Implant - 22647
BIOPRO, INC.
2019-06-12
DRILL GUIDE 15 18MM - 17650
BIOPRO, INC.
2019-06-10
MEASURING SLEEVE - 18658
BIOPRO, INC.
2019-06-06
MPJ TRIAL 20mm (MD) - 12236
BIOPRO, INC.
2019-06-06
HBS SCREW 3.0 X 16MM SDST - 20519
BIOPRO, INC.
2019-06-05
GOEZ SCREW 4.0 X 50MM - 19050
BIOPRO, INC.
2019-06-04
Hintermann Compressor - 23258
BIOPRO, INC.
2026-05-22
Hintermann Distractor - 23259
BIOPRO, INC.
2026-05-22
10mm HBS® Standard Compression - 18608
BIOPRO, INC.
2015-09-16
11mm HBS® Standard Compression - 18609
BIOPRO, INC.
2015-09-16
12mm HBS® Standard Compression - 18610
BIOPRO, INC.
2015-09-16
13mm HBS® Standard Compression - 18611
BIOPRO, INC.
2015-09-16
14mm HBS® Standard Compression - 18612
BIOPRO, INC.
2015-09-16
15mm HBS® Standard Compression - 18613
BIOPRO, INC.
2015-09-16
16mm HBS® Standard Compression - 18614
BIOPRO, INC.
2015-09-16

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