Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009973336

FEI Number

3009973336

Entity Name

Engineered Medical Systems, LLC

City/State/Country

Bartlett, TN, US

Establishment Address

3325 Appling Rd, Bartlett, TN 38133, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Engineered Medical Systems, LLC (Owner Number: 10042524)

Owner / Operator Contact Address

3325 Appling Road, Bartlett, TN 38133, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Custom Onlay Patellar Tensioner REAMER Small Oblique Inserter GAUGE, DEPTH CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS Journey STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES BRYAN CERVICAL DISC BENDER REDAPT MODULAR PROXIMALLY FLUTED HIP STEM TL Tubing Set (STERILE) PL Tubing Set (STERILE) PROBE Adapter Cap TEMPLATE FOR CLINICAL USE TOTAL KNEE SYSTEM INSTRUMENTATION TAP, BONE CD HORIZON SPINAL SYSTEM VERTE-STACK SPINAL SYSTEM Sequential Reducer X-Core Mini INTREPID SPINAL SYSTEM Inserter PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM HANDLE, SCALPEL Orthosis, spondylolisthesis spinal fixation Appliance, Fixation, Spinal Interl Orthosis, spinal pedicle fixation, for degenerative disc disease Orthosis, Spinal Pedicle Fixation Appliance, Fixation, Spinal Intervertebral Body IPC POWEREASE SYSTEM Adjustment Driver inserter Drive Shaft 8mm TL Trial TL Insertion Handle 10mm PL Trial 10mm TL Trial PL Tubing Set (STERILE) 6mm TL Trial Instrument Tray Lid Graft Insertion Cannula Insertion Handle Rotator Knob TL Insertion Handle Inner Shaft Graft Insertion Pusher PL Insertion Handle Insertion Handle End Cap TL Tubing Set (STERILE) TL Instrument Set (Long Trial Handles) Slap Hammer 8mm PL Trial 6mm PL Trial Instrument Tray Base Prep Block PL Insertion Handle Inner Shaft Instrument Tray Insert PL Instrument Set (Long Trial Handles) GUIDE, SURGICAL, INSTRUMENT Peri-Loc MALLET Syringe Body Syringe Plunger TL Tubing Set (Sterile) Syringe Body Green O-Ring PL Tubing Set (Sterile) Syringe Plunger Red O-Ring INTREPID SPINAL SYSTEM PERIMETER INTERBODY FUSION DEVICE Femoral Head/Neck Impactor Disposable Instrument Freehand Inserter Sleeve VERTE-STACK SPINAL SYSTEM Tape SMF Stem Osteotomy Guide Peri-Loc PYRAMID ANTERIOR PLATE FIXATION SYSTEM VERTE-STACK SPINAL SYSTEM PERIMETER INTERBODY FUSION DEVICE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2013-01-17
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2017-11-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-12-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-12-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-12-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-11-30
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2022-11-30
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-12-05
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2026-02-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-14
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-11-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-14
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2017-11-28
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2012-12-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2012-12-05
HXG	Tamp	Orthopedic	Class 1	888.4540	2024-11-14
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-03-13
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-03-13
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-03-13
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-12-05
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2025-11-21
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2012-12-05
HXW	Bender	Orthopedic	Class 1	888.4540	2012-12-05
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2024-11-14
HWJ	Awl	Orthopedic	Class 1	888.4540	2012-12-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-05
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-05-05
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2024-05-08
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-03-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-14
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-11-14
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2024-11-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-06-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-02-15
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-02-15
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-02-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-14
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-11-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-14
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-06-14
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2024-05-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-24
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-04-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-08-24
HXB	Probe	Orthopedic	Class 1	888.4540	2012-12-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-11-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-01-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-01-17
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2013-01-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-01-17
IXH	Camera, Focal Spot, Radiographic	Radiology	Class 1	892.1940	2024-03-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-01-27
HWT	Template	Orthopedic	Class 1	888.4800	2012-12-05
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3550	2013-03-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-03-13
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-03-13
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-03-13
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-03-13
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-03-13
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2013-03-13
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-03-13
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-12-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-02-27
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-02-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-02-27
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2026-02-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-02-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-12-05
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-12-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-12-05
NQP	Posterior Metal/Polymer Spinal System, Fusion	Orthopedic	Class 2	888.3070	2012-12-05
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-12-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-12-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-12-10
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-11-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-11-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-11-28
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2017-11-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-11-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-11-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-14
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-11-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-12-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2025-01-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-14
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2024-11-14
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2012-12-05
HWA	Impactor	Orthopedic	Class 1	888.4540	2023-02-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-11-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-12-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-06-19
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2023-02-15
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2012-12-05
QLR	Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices	Orthopedic	Class 2	888.4520	2025-12-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-11-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-11-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-11-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-11-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-11-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-11-19
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-12-05
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-12-05
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2012-12-05
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2017-11-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-11-28
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2017-11-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-12-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-11-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-11-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-08-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-12-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-11-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-11-02
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-04-24
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-04-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-03-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-03-13
JDO	Device, Fixation, Proximal Femoral, Implant	Orthopedic	Class 2	888.3030	2013-03-13
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2012-12-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-08-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-11-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-12-05
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2017-12-28
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-12-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-12-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-05
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2013-11-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-11-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-11-19
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2013-11-19
FLS	Monitor, Apnea, Facility Use	Anesthesiology	Class 2	868.2377	2013-11-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-11-19
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2013-11-19
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2013-11-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-11-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-11-19
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2013-11-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-05-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-24
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-12-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-11-28
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-11-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-12-05
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-05-08
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2017-12-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-12-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-12-28
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Orthopedic	Class 2	888.3360	2013-11-19
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2013-11-19
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	General, Plastic Surgery	Class 2	878.3300	2013-11-19
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-11-19
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-11-19
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-11-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-11-19
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Orthopedic	Class 2	888.3360	2013-11-19
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-11-19
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-11-19
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-11-19
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-11-19
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2013-11-19
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-12-05
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2012-12-05
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-11-19
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2023-02-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-12-05

Official Correspondent

Dwayne Wisham

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Engineered Medical Systems, 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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009973336. Last updated year: 2026. Please use registration number 3009973336 when referencing this establishment in official correspondence.