ZAVATION

FDA Device Registration & Listing · Flowood, MS, US · Registration 3008583793

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
3008583793
FEI Number
3008583793
Entity Name
ZAVATION
City/State/Country
Flowood, MS, US
Establishment Address
3670 Flowood Dr, Flowood, MS 39232, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Zavation Medical Products LLC (Owner Number: 10055475)
Owner / Operator Contact Address
3670 Flowood Dr, Flowood, MS 39232, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR InterV Bone Access Cannula; InterV Bone Access Needle; Blue Diamond Digital Inflation InterV Curette; InterV Direct Access Needle Vertebrex Bone Access Needle; Vertebrex Curette; InterV Drill; InterV Flex Needle; Vertebrex Kirschner Wire; ZV Plasty Direct Access Needle InterV Kirschner Wire; Vertebrex Bone Access Cannula; Vertebrex Direct Access Needle; Vertebrex Drill; Vertebrex Flex Needle Atrion QL2530 Inflation Device Bender APPLIANCE, FIXATION, SPINAL INTERLAMINAL ORTHOPEDIC STEREOTAXIC INSTRUMENT Zavation IBF EZ Plate InterV Kyphoplasty Catheter (Micro)/Kit; InterV Kyphoplasty Catheter (Mini)/Kit; InterV Kyphoplasty Catheter/Kit; Vertebrex Kyphoplasty Catheter (Flex)/Kit; Vertebrex Kyphoplasty Catheter (Micro)/Kit; Vertebrex Kyphoplasty Catheter (Mini)/Kit; 11G Renova Spine Balloon Catheter/Kit; InterV Kyphoplasty Catheter (Flex)/Kit; ZV Plasty Kyphoplasty Catheter (Mini) Vertebrex Kyphoplasty Catheter/Kit; ZV Plasty Kyphoplasty Catheter Ti 3Z Interbody System Zavation Ti3Z Cervical System INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR SPINAL INTERVERTEBRAL BODY TIGER SPINE SYSTEM RASP, SURGICAL, GENERAL & PLASTIC SURGERY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Wrench APPLIANCE, FIXATION, SPINAL INTERLAMINAL SI Screw System ZMI-90 Mixing and Injection System Labyrinth Zavation Cervical Plate System NanoPrime System Tap, Bone Z-Span Plate System INSTRUMENT, BENDING OR CONTOURING InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20 mm) InterV Kyphoplasty Catheter (Balloon lengthL 10;15 and 20 mm) UNIFUZE INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL Zavation Connector System Normandy VBR System Zavation Z-Link Lumbar CoreLink® M3™ Stand-Alone Anterior Lumbar System Unifuze-C Bone Strip ZAVATION CERVICAL PLATE SYSTEM Wire Cutter ZV Graft RONGEUR Broach Z-Clamp ISP System F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System Tiger 2 System Zavation VariSync™ System Z-LINK CERVICAL Spinal Interlaminal INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) ZVPLASTY VCF-1020-DBK 10 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-DDBAK-11 Direct Double Bone Access Kit 11ga VCF-1110-SBK 11 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-DSSKbd-13 Single Bone Access kit for Injection 13ga VCF-1010-1 10 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1023-11-S 11ga Diamond Stylet VCF-1100-10, 11 Gauge 10mm Kyphoplasty Balloon VCF-1010-11 11ga Biopsy Device VCF-1023 10ga Diamond Trocar VCF-1010-2 10 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-FLCU-11 InterV Flex Curved Cannula, 11G VCF-1023-8-S 8ga Diamond Stylet VCF-1120-FLEX 20mm Flex Direct Unilateral Kyphoplasty Balloon VCF-1010-13 13ga Biopsy Device VCF-1020-SBK 10 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1000-10 10 Gauge 10mm Kyphoplasty Balloon VCF-1006-11 11ga Drill VCF-1020-FLEX 10 Gauge 20mm Flex Direct Unilateral Kyphoplasty Kit VCF-1080-L Directional Cement Cannula (Long with Tuhoy Connection) VCF-DCDK-13 Double Cement Delivery Kit 13ga (8-Pack) VCF-15-CPL Curve Plus 15mm VCF-1315-DBK 13 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1110-FLEX 10mm Flex Direct Unilateral Kyphoplasty Balloon VCF-1015-SBK 10 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1115-SBK 11 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1115-DBK 11 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1110-2 11 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-1310-1 13 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1310-SBK 13 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-1020-1 10 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1010-DBK 10 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-DCDK Double Cement Delivery Kit 10ga (8-Pack) VCF-1320-2 13 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1110-1 11 Gauge 10mm Direct Unilateral Kyphoplasty Kit VCF-1120-DBK 11 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-1120-2 11 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1080-S Directional Cement Cannula VCF-DSBAK Direct Single Bone Access Kit 10ga VCF-10-CPL Curve Plus 10mm VCF-1000-20, 10 Gauge 20mm Kyphoplasty Balloon VCF-1022 10ga Beveled Trocar VCF-1006-8 8ga Drill VCF-1300-20 13 Gauge 20mm Kyphoplasty Balloon VCF-1023-13-S 13ga Diamond Stylet VCF-1015-FLEX 10 Gauge 15mm Flex Direct Unilateral Kyphoplasty Kit VCF-DSBAK-13 Direct Single Bone Access Kit 13ga VCF-SCDK Single Cement Delivery Kit 10ga (5-Pack) VCF-1300-15 13 Gauge 15mm Kyphoplasty Balloon VCF-1320-DBK 13 Gauge 20mm Double Kyphoplasty Balloon Kit VCF-1022-8 8ga Beveled Trocar VCF-1022-11 11ga Beveled Trocar VCF-1120-SBK 11 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1070-11 11ga co-ax cannulas VCF-1015-1A 10 Gauge 15mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1015-1 10 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-1023-8 8ga Diamond Trocar VCF-1115-1 11 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-1320-1 13 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1006 10ga Drill VCF-1000-15, 10 Gauge 15mm Kyphoplasty Balloon VCF-1080-S4 Directional Cement Cannula 4-Pack VCF-20-CPL Curve Plus 20mm VCF-SCDK-13 Single Cement Delivery Kit 13ga (5-Pack) VCF-DDSKbd Double Bone Access Kit for Injection 10ga VCF-1022-S 10ga Beveled Stylet VCF-1120-1 11 Gauge 20mm Direct Unilateral Kyphoplasty Kit VCF-1100-20 11 Gauge 20mm Kyphoplasty Balloon VCF-1007-11 11ga Cement Cannula VCF-1010-1A 10 Gauge 10mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1100-15 11 Gauge 15mm Kyphoplasty Balloon VCF-1022-8-S 8ga Beveled Stylet VCF-DDBAK-13 Direct Double Bone Access Kit 13ga VCF-1007 10ga Cement Cannula VCF-DSSKbd Single Bone Access kit for Injection 10ga VCF-FLCU-10 InterV CurvePlus Curved Cannula, 10G VCF-1300-10-L 13 Gauge 10mm Kyphoplasty Balloon (Long) VCF-1022-13-S 13ga Beveled Stylet VCF-1310-DBK 13 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-1300-10 13 Gauge 10mm Kyphoplasty Balloon VCF-1010-2A 10 Gauge 10mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1310-2 13 Gauge 10mm Direct Bilateral Kyphoplasty Kit VCF-SCDK-11 Single Cement Delivery Kit 11ga (5-Pack) VCF-1300-20-L 13 Gauge 20mm Kyphoplasty Balloon (Long) VCF-DDSKbd-11 Double Bone Access Kit for Injection 11ga VCF-1115-2 11 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-1020-2A 10 Gauge 20mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1007-8 8ga Cement Cannula VCF-1010-SBK 10 Gauge 10mm Single Kyphoplasty Balloon Kit VCF-1300-15-L 13 Gauge 15mm Kyphoplasty Balloon (Long) VCF-1015-2 10 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-1022-11-S 11ga Beveled Stylet VCF-1020-1A 10 Gauge 20mm Direct Unilateral Additional Level Kyphoplasty Kit VCF-1010-FLEX 10 Gauge 10mm Flex Direct Unilateral Kyphoplasty Kit VCF-DSBAK-11 Direct Single Bone Access Kit 11ga VCF-1320-SBK 13 Gauge 20mm Single Kyphoplasty Balloon Kit VCF-1006-13 13ga Drill K05-02650 Digital Inflation Device VCF-1315-2 13 Gauge 15mm Direct Bilateral Kyphoplasty Kit VCF-1022-13 13ga Beveled Trocar VCF-1315-1 13 Gauge 15mm Direct Unilateral Kyphoplasty Kit VCF-DDSKbd-13 Double Bone Access Kit for Injection 13ga VCF-KVTGUN-DS BPB Injector VCF-1015-DBK 10 Gauge 15mm Double Kyphoplasty Balloon Kit VCF-1007-13 13ga Cement Cannula VCF-CCUR-11 InterV Flex Curved Curette, 11G VCF-1020-2 10 Gauge 20mm Direct Bilateral Kyphoplasty Kit VCF-1015-2A 10 Gauge 15mm Direct Bilateral Additional Level Kyphoplasty Kit VCF-1023-11 11ga Diamond Trocar VCF-1115-FLEX 15mm Flex Direct Unilateral Kyphoplasty Balloon VCF-DCDK-11 Double Cement Delivery Kit 11ga (8-Pack) VCF-1070 10ga co-ax cannulas VCF-DSSKbd-11 Single Bone Access kit for Injection 11ga VCF-1023-13 13ga Diamond Trocar VCF-DDBAK Direct Double Bone Access Kit 10ga VCF-1315-SBK 13 Gauge 15mm Single Kyphoplasty Balloon Kit VCF-1110-DBK 11 Gauge 10mm Double Kyphoplasty Balloon Kit VCF-1023-S 10ga Diamond Stylet VCF-1010 10ga Biopsy Device SPINAL INTERVERTEBRAL BODY ACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Varisync® ALIF System Template Uni-FuZe-P Bone Putty Zavation Fenestrated Facet Screw System INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR ZAVATION CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Zavation IBF System SPONDYLOLISTHESIS SPINAL FIXATION Zavation eZspand Interbody System SPONDYLOLISTHESIS SPINAL FIXATION Sacroiliac Joint Fixation SPINAL INTERVERTEBRAL BODY Reamer SPONDYLOLISTHESIS SPINAL FIXATION ORTHOPEDIC STEREOTAXIC INSTRUMENT Awl Zavation MILC System Zavation Spinal System PASSER, WIRE, ORTHOPEDIC INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Unifuze Putty SCREW, FIXATION, BONE CoreLink Navigation Instruments ZAVATION IBF SYSTEMS Zavation Spinal System ORTHOPEDIC STEREOTAXIC INSTRUMENT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Normandy Cervical VBR System Tamp

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2019-03-22
HXW Bender Orthopedic Class 1 888.4540 2023-11-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-11-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-11-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-11-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-11-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-07-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-07-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-02-23
HRX Arthroscope Orthopedic Class 2 888.1100 2019-03-22
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-03-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-05-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-04-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-11-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-11-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-11-13
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-11-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-11-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-11-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
HXC Wrench Orthopedic Class 1 888.4540 2023-11-13
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2023-11-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-11-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-04-04
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2018-04-04
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2025-11-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-08-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-08-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-07-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-09-05
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-09-05
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-09-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-09-05
HWX Tap, Bone Orthopedic Class 1 888.4540 2023-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-07-28
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2023-11-13
HRX Arthroscope Orthopedic Class 2 888.1100 2019-03-26
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-03-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-01-17
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-07-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-07-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-07-01
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2024-07-01
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2019-08-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-08-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-07-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-03
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-07-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-07-28
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2023-11-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-01-22
HTX Rongeur Orthopedic Class 1 888.4540 2023-11-13
HTQ Broach Orthopedic Class 1 888.4540 2023-11-13
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2017-07-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-01-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-03
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-05-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-05-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-05-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-08-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-08-22
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-08-22
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-07-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-11-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-11-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-11-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-11-13
HRX Arthroscope Orthopedic Class 2 888.1100 2019-03-26
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-03-26
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2017-07-28
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-28
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-11-13
LYQ Accessories, Fixation, Spinal Intervertebral Body Orthopedic Class 1 888.4540 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-11-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2023-11-13
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2023-11-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-11-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-11-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-12-22
HWT Template Orthopedic Class 1 888.4800 2023-11-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-07-30
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2018-05-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-07-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-07-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-07-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-11-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-11-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-11-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-11-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-11-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-11-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-11-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-11-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-11-13
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-11-13
HTO Reamer Orthopedic Class 1 888.4540 2023-11-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-11-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-11-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-11-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-11-13
HWJ Awl Orthopedic Class 1 888.4540 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-10-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-10-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-03-02
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2023-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-11-13
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2025-06-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-11-13
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-11-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-07-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-07-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-07-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-07-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-07-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-11-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-03-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-03-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-11-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-07-25
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2018-07-25
HXG Tamp Orthopedic Class 1 888.4540 2023-11-13

Official Correspondent

Elke Carter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zavation Medical Products 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
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

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 3008583793. Last updated year: 2026. Please use registration number 3008583793 when referencing this establishment in official correspondence.
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