BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SINGLE SOURCE MEDICAL LLC

    Reg #: 3010386387 · FEI: 3010386387 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    146
    Establishment Types
    2
    Classifications
    47

    Registration Details

    Registration Name
    SINGLE SOURCE MEDICAL LLC
    Registration Number
    3010386387
    FEI Number
    3010386387
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4506 S State Road 9 57
    City
    Churubusco
    State
    IN
    ZIP
    46723
    Country
    US

    Owner / Operator

    Firm Name
    Single Source Medical LLC
    Operator Number
    10043888
    Address
    4506 IN 9-57
    City
    Churubusco
    State
    IN
    Postal Code
    46723
    Country
    US
    Correspondent
    Tom Harris

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Forceps, Wire Holding HYA
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Washer, Bolt Nut HTN
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Wrench HXC
    Tamp HXG
    Chisel, Surgical, Manual FZO
    Guide, Surgical, Instrument FZX
    Growing Rod System PGM
    Retractor GAD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Osteotome HWM
    Impactor HWA
    Template HWT
    Driver, Prosthesis HWR
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Rasp HTR
    Screwdriver HXX
    Instrument, Manual, Surgical, General Use MDM
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Awl HWJ
    Bit, Drill HTW
    Extractor HWB
    Gauge, Depth HTJ
    Rod, Fixation, Intramedullary And Accessories HSB

    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 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 Intramedullary Tribial Cut Guide Jig 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 SN 4786 F-F 7200-1034 SLAP HAMMER 2106-1002 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 ORTHOPEDIC SURGICAL INSTRUMENT SN 6314 A-A GAGE SSI006692 ZNN Retro Targeting Guide Extended SSI006705 Retro Nail Depth Gauge +5 cm SSI006704 Retro Nail Connect Bolt + 5cm Zimmer Persona Knee System Box Cut Guide SN 4991 K-K PERSONA MONOLITHIC ARTICULAR SURFACE TRIALS-CR SN 4991 H-H Single Piece CR Persona Tibial Articular Surface Trial AWL 5210-1022 AWL Drill Bit 4.3 mm SN 4510 E-E EXTRACTOR EXTRACTOR 5210-1048 Biomet Extractor SN 6059 B-B MODIFIED LEFT AND RIGHT PERSONA PARTIAL KNEE TIBIAL CUT BLOCKS SN 5101 D-D TARGETING GUIDE AF CONNECTING BOLT 82-0199-037-03

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only