LIFE SCIENCE OUTSOURCING, INC.

FDA Device Registration & Listing · Brea, CA, US · Registration 2031093

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2031093
FEI Number
3001236549
Entity Name
LIFE SCIENCE OUTSOURCING, INC.
City/State/Country
Brea, CA, US
Establishment Address
830 Challenger Street, Brea, CA 92821, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Life Science Outsourcing, Inc. (Owner Number: 10024857)
Owner / Operator Contact Address
830 Challenger Street, Brea, CA 92821, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 ACCESSORY,BARIUM SULFATE,METHYL METHACRYLATE FOR CRANIOPLASTY Spinal Process Fusion Plate SPIWay Osteo-P Bone Graph Substitute TriMed Ripcord Device CM-1501 ACL Disposable Procedure Kit 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 FLUOPTICS SAS 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 CM-1501 ACL Disposable Procedure Kit LabraLink Suture Anchor CM-7610 Acc Portal Kit w/Low Profile Drill 10mm CM-7609 Acc Portal Kit w/Low Profile Drill 9mm CM-1501 ACL Disposable Procedure Kit CM-7611 Acc Portal Kit w/Low Profile Drill 11mm 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-26
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2018-10-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-26
MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2014-07-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-08
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2015-03-12
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2015-03-12
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2015-03-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-26
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2015-09-03
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2015-03-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-26
HTW Bit, Drill Orthopedic Class 1 888.4540 2015-05-07
HWX Tap, Bone Orthopedic Class 1 888.4540 2020-02-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-02-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-03-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-03-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-03-24
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-12-26
HRX Arthroscope Orthopedic Class 2 888.1100 2016-06-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-08-28
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2014-07-11
LOD Bone Cement Orthopedic Class 2 888.3027 2014-07-11
QDG Parathyroid Autofluorescence Imaging Device General, Plastic Surgery Class 2 878.4550 2023-06-06
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2024-04-26
LRK Device, Anti-Snoring Dental Class 2 872.5570 2022-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-03-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-03-24
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2015-05-27
OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2015-05-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-26
MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2014-07-11
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2016-09-16
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2025-09-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-07-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-11-02
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-04-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-11-22
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2012-12-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-03-06
DTI Sizer, Heart-Valve, Prosthesis Cardiovascular Class 1 870.3945 2023-03-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-05-15
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2025-06-09
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2023-06-06
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2023-03-09
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2015-03-12
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2015-03-12
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2015-03-12
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2015-03-12
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-08-17
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2021-01-27
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2023-06-06
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-12-26
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2015-09-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-03-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-26
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2012-12-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-11-07
KPE Container, I.V. General Hospital Class 2 880.5025 2014-12-02
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2013-11-01
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2024-07-29
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2017-04-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2012-12-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-04-13
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2019-02-14
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2023-03-09
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-12-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-09-09
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-09-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-09-09
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2016-03-11
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2021-11-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-26
DYE Replacement Heart-Valve Cardiovascular Class 3 870.3925 2012-12-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2012-12-26

Official Correspondent

Mireya Lozano

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Life Science Outsourcing, Inc.
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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031093. Last updated year: 2026. Please use registration number 2031093 when referencing this establishment in official correspondence.
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