Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010386387

FEI Number

3010386387

Entity Name

SINGLE SOURCE MEDICAL LLC

City/State/Country

Churubusco, IN, US

Establishment Address

4506 S State Road 9 57, Churubusco, IN 46723, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Single Source Medical LLC (Owner Number: 10043888)

Owner / Operator Contact Address

4506 IN 9-57, Churubusco, IN 46723, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

32-700188 32-700083 32-700184 32-700150 32-700185 32-700119 VANGUARD XP KNEE SYSTEM 32-700078 32-700152 32-700148 32-700153 32-700084 32-700149 32-700116 32-700183 32-700080 32-700113 32-700151 32-700115 32-700081 32-700079 32-700118 32-700186 32-700187 32-700117 32-700114 32-700082 GLENOSPHERE INSERTER INSERTER SN 6125 C-C Comprehensive Modular Hybrid Glenoid Modular Radial Head Replacement Device 100255 component pad 100260 component inner o-ring 100261 component outer o-ring 100252 component base 100283 component sleeve 10274 component sleeve 100245 component grub screw 100248 component lock screw 100251 component base 100254 component pad 100259 component lower bushing 100275 component sleeve 100285 component sleeve 100258 component upper bushing 100284 component sleeve 100273 lock screw 100244 component grub screw ring 100253 component pad 100257 component flat washer 100249 component spindle release 100250 component base 100247 component cap 100277 component sleeve 100256 component washer ATTACHMENT, MANUAL SURGICAL INSTRUMENT Biomet Wrench CERVICAL TAMP Persona box cut guide chisel Biomet Guide Surgical Instrument 82-0164-033-00 PATELLA TOOL MODULAR PATELLA MILL SN 6158 A-A SN 4852 AD-AD Intramedullary tibial cut guide jig and boom connector for Persona TKA system Boom Connector for Surgical Guide SN 4852 AB-AB SN 6386 A-A REV C Bushing Connection Body Patella Cutters SN 5020 D-D SN 4934 B-B Placement Guide SN 6325 A-A TRIGGER STYLE HIP STEM INSERTER 01-1721-1500 Verteglide 4.5mm Manual Counter Torque Tube RETRACTOR RETRACTOR 7200-1035 SN 6125 C-C Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate CHISEL 7200-1013 CHISEL IMPACTOR IMPACTOR 7200-1011 Biomet Impactor Biomet Template COMPREHENSIVE REVERSE HUMERAL TRIAL SN 5192 Y-Y HOLDER INSERTER 2300-1311 INSERTER 2300-1310 HOLDER 2300-1015 INSERTER G7 Acetabular Cup SN 61488 A-A 31-479562 BIPOLAR/ENDO PROV CUP 28X52MM 31-479560 BIPOLAR/ENDO PROV CUP 28X50MM 31-479561 BIPOLAR/ENDO PROV CUP 28X51MM 31-479552 BIPOLAR/ENDO PROV CUP 28X42MM 31-479568 BIPOLAR/ENDO PROV CUP 28X58MM 31-479565 BIPOLAR/ENDO PROV CUP 28X55MM 31-479551 BIPOLAR/ENDO PROV CUP 28X41MM 31-479555 BIPOLAR/ENDO PROV CUP 28X45MM 31-479553 BIPOLAR/ENDO PROV CUP 28X43MM 31-479554 BIPOLAR/ENDO PROV CUP 28X44MM 31-479557 BIPOLAR/ENDO PROV CUP 28X47MM 31-479559 BIPOLAR/ENDO PROV CUP 28X49MM 31-479558 BIPOLAR/ENDO PROV CUP 28X48MM 31-479563 BIPOLAR/ENDO PROV CUP 28X53MM 31-479564 BIPOLAR/ENDO PROV CUP 28X54MM 31-479556 BIPOLAR/ENDO PROV CUP 28X46MM Orthopedic Manual Surgical Instrument Extended Exact Broach Handle SN 6325 A-A TRIGGER STYLE HIP STEM INSERTER Intramedullary Tribial Cut Guide Jig SN 6386 A-A REV C TIBIAL CUT GUIDE L & R SN 4808 F-F Intramedullary Tibial Cut Guide Jig for the Persona TKA system SN 4852 AB-AB Intramedullary Tibial Cut Guide Jig for the Persona TKA system SN 4852 AD-AD SN 5181 K-K Tibial resection Guide SN 5379 Left and Right Tibial cut Guide SN 4808 F-F SN 6069 D-D MODIFIED CUP INSERTER 82-0164-033-00 PATELLA TOOL SN 4786 F-F 7200-1034 SLAP HAMMER 2106-1002 INSERTER SLAP HAMMER SLAP HAMMER 7200-1065 DISSECTOR DISSECTOR 7200-1041 SSI006764 Double Bundle Femoral Aimer 11 mm SSI006765 Double Bundle Femoral Aimer 12mm RASP SN 2987 B-B RASP RASP 7200-1007 Compress Segmental Femoral Replacement System DRIVER 5210-1004 DRIVER 5210-1005 DRIVER SSI006624 HEX DRIVER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-08-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-08-22
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2019-08-22
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-08-22
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2019-09-25
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-06-06
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-09-13
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-09-13
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2013-04-05
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-07-01
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	Class 2	888.4580	2019-02-22
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-04-05
HXG	Tamp	Orthopedic	Class 1	888.4540	2018-11-30
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2019-04-22
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-04-05
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2026-04-28
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2021-06-06
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2019-09-13
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-09-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-09-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-09-13
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2019-09-13
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2021-06-06
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-04-05
HWT	Template	Orthopedic	Class 1	888.4800	2013-04-03
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2013-04-02
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2021-06-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-08-22
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-08-22
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2019-08-22
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2019-08-22
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2019-08-22
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2019-08-22
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-08-22
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-03-16
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-03-16
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2023-03-16
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-03-16
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2023-03-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-04-03
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-04-02
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-04-02
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-04-02
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2013-04-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-04-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-04-02
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2013-04-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-04-02
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-04-02
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2019-09-10
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-04-05
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2021-06-06

Official Correspondent

Tom Harris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Single Source Medical LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17
K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	2025-10-24
K243247	Zimmer, Inc.	Persona the Personalized Knee System	2024-10-29
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010386387. Last updated year: 2026. Please use registration number 3010386387 when referencing this establishment in official correspondence.