BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LIFE SCIENCE OUTSOURCING, INC.

    Reg #: 2031093 · FEI: 3001236549 · Expires 2026
    View on FDA
    Products
    59
    Proprietary Names
    142
    Establishment Types
    3
    Classifications
    59

    Registration Details

    Registration Name
    LIFE SCIENCE OUTSOURCING, INC.
    Registration Number
    2031093
    FEI Number
    3001236549
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    830 Challenger Street
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190891

    Owner / Operator

    Firm Name
    Life Science Outsourcing, Inc.
    Operator Number
    10024857
    Address
    830 Challenger Street
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Mireya Lozano

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Spinal Vertebral Body Replacement Device MQP
    Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty MYU
    Orthopedic Stereotaxic Instrument OLO
    Electromyograph, Diagnostic IKN
    Stimulator, Electrical, Evoked Response GWF
    Stimulator, Nerve ETN
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Bit, Drill HTW
    Tap, Bone HWX
    Mesh, Surgical, Polymeric FTL
    Arthroscope HRX
    Cement, Bone, Vertebroplasty NDN
    Bone Cement LOD
    Parathyroid Autofluorescence Imaging Device QDG
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Device, Anti-Snoring LRK
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Spinous Process Plate PEK
    Splint, Intranasal Septal LYA
    Filler, Bone Void, Calcium Compound MQV
    Washer, Bolt Nut HTN
    Cannula, Surgical, General & Plastic Surgery GEA
    Ring, Annuloplasty KRH
    Sizer, Heart-Valve, Prosthesis DTI
    Confocal Optical Imaging OWN
    Passer, Wire, Orthopedic HXI
    Neurological Stereotaxic Instrument HAW
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Retractor, Self-Retaining, For Neurosurgery GZT
    Tube, Gastro-Enterostomy KGC
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Implant, Endosseous, Orthodontic OAT
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Container, I.V. KPE
    Marker, Skin FZZ
    Orthopedic Manual Surgical Instrument LXH
    File, Pulp Canal, Endodontic EKS
    Gauge, Depth HTJ
    Pin, Fixation, Smooth HTY
    Accessories, Arthroscopic NBH
    Replacement Heart-Valve DYE
    Low Energy Direct Current Thermal Ablation System OAB
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Scalpel, One-Piece GDX
    Awl HWJ
    System, Balloon, Intra-Aortic And Control DSP
    Needle, Suturing, Disposable GAB
    Device, Thermal Ablation, Endometrial MNB
    Reamer HTO
    Wound Retraction And Protection System PQI
    Needle, Hypodermic, Single Lumen FMI
    Light, Surgical, Fiberoptic FST
    Drills, Burrs, Trephines & Accessories (Manual) HBG

    Proprietary Names

    Exomed Arcphix And Exomed Arrowphix FixxSure cross link Sonata Radiofrequency Ablation Handpiece and the Sonata Case Kit Stansion Matrix ACCESSORY,BARIUM SULFATE,METHYL METHACRYLATE FOR CRANIOPLASTY Orthopedic Stereotaxic Instrument Inframe Cannulated Fixation System NuVasive NVJJB System Exomed ltn Cannulated Screw System AperFix® AM Femoral Implant with Inserter Freedom SCS System Stimulation/dissection Instruments Alif Intervertebral fusion device with bone graft, lumbar SureLock Drill, 2.2mm SureLock Drill, Flex 2.2mm SureLock Drill, 1.4mm SureLock Drill, Flex, 1.4mm CM-9560 Accessory Drill Kit, 6mm CM-9570 Accessory Drill Kit, 7mm CM-9580 Accessory Drill Kit, 8mm CM-9540 Accessory Drill Kit, 4mm CM-9550 Accessory Drill Kit, 5mm CM-7609 Acc Portal Kit w/Low Profile Drill 9mm CM-7611 Acc Portal Kit w/Low Profile Drill 11mm CM-1501 ACL Disposable Procedure Kit CM-7610 Acc Portal Kit w/Low Profile Drill 10mm CM-7014 AperFix Drill Tip Guide Wire (2.4mm) 14" Drill, for 5.5mm Ventix Link Knotless Anchor Drill, for 4.75mm Ventix Link Knotless Anchor Thermally Hardened Cannulated Drill Bit (various) ExoMed Cannulated Drill Tap, for 5.5mm Ventix Link Knotless Anchor Tap, for 4.75mm Ventix Link Knotless Anchor Ventix Link Knotless Anchor 4.75mm PEEK Anchor Ventix Link Knotless Anchor 5.5mm PEEK Anchor Quattro GL Quattro Link Soft Tissue Assist Device X- Repair HRX-ARTHROSCOPE AppianFx Tissue Suture Anchor BONE CEMENT FLUOPTICS SAS Overture Ti Elevo Set Snoring Intervention Device Quattro X Insightra Freedon Ventral Hernia Repair System KneeAlign 2 Spinal Process Fusion Plate SPIWay Osteo-P Bone Graph Substitute TriMed Ripcord Device OrthAlign Plus System CM-2509AFX, AFX FEMORAL IMPLANT 9X25MM CM-2510AFX, AFX FEMORAL IMPLANT 10X25MM Profile 3D Annuloplasty Ring SureLock Anchors 7680S Profile 3D Sizer Set TOOl 7690SD CNTOUR 3D SZRSET SNGLUSE 26L Screw, Fixation, Bone CM-9509 Quattro® Bolt Tendesis Screw, 9mm by 16mm CM-9508 Quattro® Bolt Tendesis Screw, 8mm by 16mm CM-9508 Quattro® Bolt Tendesis Screw, 6mm by 16mm CM-9508 Quattro® Bolt Tendesis Screw, 5mm by 16mm CM-9508 Quattro® Bolt Tendesis Screw, 7mm by 16mm SPIWAY Endonasal Access Guide Guide Wire, Single Trocar NuVasive NVM5 System MyEllevate VYCOR VIEWSITE BRAIN ACCESS SYSTEM WITH ALIGMENT CLIP PUMA-G System Plateav-C VectorTAS Mini Screw Innate Cannulated Screw System SmartPlate Gradient Plus System Plateav Contour 3D Annuloplasty Ring CM-6101 BioWick SureLock Drill, 2.7mm CM-6101H Hard Bone Drill, 2.7mm, BioWick SureLock CM-6120 NBH, Drill Guide, for BioWick SureLock CM-6127 BioWick SureLock Anchor with Inserter, 2.7mm CM-6121 NBH, Obturator, for BioWick SureLock Reservoir Bag Amplify LabraLink Suture Anchor ExoMed Torx Driver Guide Sleeve (various), Inserter Handle (various) 818-2132 Traverse Rotary Glide Path File - 6/.13/25mm - N 818-2147 Traverse Orifice and Glide Path File - 6/.13/25mm - R 818-2157 Traverse Rotary Glide Path File - 6/.13/25mm - R 818-2156 Traverse Rotary Glide Path File - 6/.13/21mm - R 818-2191 Traverse Orifice and Glide Path File - 6/.18/21mm - N 818-2193 Traverse Orifice and Glide Path File - 6/.18/31mm - N 818-2197 Traverse Orifice and Glide Path File - 6/.18/25mm - R 818-2186 Traverse Rotary Glide Path File - 6/.18/21mm - R 818-2142 Traverse Orifice and Glide Path File - 6/.13/25mm - N 818-2141 Traverse Orifice and Glide Path File - 6/.13/21mm - N 818-2143 Traverse Orifice and Glide Path File - 6/.13/31mm - N 818-2148 Traverse Orifice and Glide Path File - 6/.13/31mm - R 818-2182 Traverse Rotary Glide Path File - 6/.18/25mm - N 818-8251 Traverse Orifice Opener - 8/.25/17mm - N 818-2188 Traverse Rotary Glide Path File - 6/.18/31mm - R 818-2158 Traverse Rotary Glide Path File - 6/.13/31mm - R 818-2183 Traverse Rotary Glide Path File - 6/.18/31mm - N 818-2198 Traverse Orifice and Glide Path File - 6/.18/31mm - R 818-2196 Traverse Orifice and Glide Path File - 6/.18/21mm - R 818-2146 Traverse Orifice and Glide Path File - 6/.13/21mm - R 818-8256 Traverse Orifice Opener - 8/.25/17mm - R 818-2131 Traverse Rotary Glide Path File - 6/.13/21mm - N 818-2133 Traverse Rotary Glide Path File - 6/.13/31mm - N 818-2192 Traverse Orifice and Glide Path File - 6/.18/25mm - N 818-2181 Traverse Rotary Glide Path File - 6/.18/21mm - N 818-2187 Traverse Rotary Glide Path File - 6/.18/25mm - R Implant Sizer CrossFix II Meniscal Repair Device Extremity All Suture System CM-9301, QUATTRO DRILL GUIDE 2.9MM CM-9302, QUATTRO OBTURATOR BLUNT 2.9MM AperFix Interference Screw Hancock Left Ventricle Connector KneeAlign HA minuteman G3 MIS Fusion Plate C Safe, Scalpel, One-piece Awl/Punch, 4.75/5.5mm Ventix Link Tapered Awl/Punch, 4.75/5.5mm Ventix Link CM-6265 BioWick X Implant (PEEK), 6.5mm Implant Pre-loaded with (3) Size 2 UHMWPE Suture Strands CM-6201 HWX, Tap, for 5.5mm BioWick X Implant CM-6202 HWX, Tap, for 6.5mm BioWick X Implant CM-6255 BioWick X Implant (PEEK), 5.5mm Implant Pre-loaded with (2) size 2 UHMWPE Suture Strands AperFix Tibial Implant with Inserter Minuteman G5 Quattro Suture Passer Needle Needle (various) Minuteman G5 MIS Fusion Plate AperFix Femoral Implant with Inserter AMP-150, Amplify Surface Activated Bone Graft Putty, Large AMP-037, Amplify Surface Activated Bone Graft Putty, Small AMP-075, Amplify Surface Activated Bone Graft Putty, Medium ProFlor, Mesh, surgical Polymeric CM-7111ST Femoral Removal Coring Reamer 11mm CM-7110ST Femoral Removal Coring Reamer 10mm CM-7109ST Femoral Removal Coring Reamer 9mm Wound Retraction and Protection System Blunt Cannula NuVassive MaXcess Light Guide FP-VNTRC KIT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer) Repack or Relabel Medical Device