Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012429289

FEI Number

3012429289

Entity Name

XENIX MEDICAL

City/State/Country

Orlando, FL, US

Establishment Address

149 W Michigan St, Orlando, FL 32806, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Xenix Medical (Owner Number: 10051846)

Owner / Operator Contact Address

149 W Michigan St., Orlando, FL 32806, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170318

PMA Number

N/A

All Registered Proprietary Names

Xenix Medical Sacroiliac Fixation System RIVA Posterior Fixation System Screw Adjuster RIVA Posterior Fixation System Shank Head Adjuster - Grey RIVA Posterior Fixation System Head Turner - T-Handle RIVA Posterior Fixation System Set Screw Inserter - Long RIVA Posterior Fixation System Head Turner - Axial RIVA Posterior Fixation System Head Remover RIVA Posterior Fixation System Set Screw Inserter RIVA Posterior Fixation System Set Screw Inserter - Short RIVA Posterior Fixation System Shank Head Adjuster - Green RIVA Posterior Fixation System BONE SCREW INSERTER RIVA Posterior Fixation System Set Screw Inserter, Double Sided RIVA Posterior Fixation System Rod Inserter RIVA Posterior Fixation System Head Inserter TiWave TiWave-C neoWave C Ti3D RIVA Posterior Fixation System Bone Reamer TiWave-L TiWave neoWave LS Ti3D RIVA Posterior Fixation System Reduction Head Caddy Base RIVA Posterior Fixation System Standard Head Caddy Lid RIVA Posterior Fixation System 5.5 Cross Connector Caddy Lid RIVA Posterior Fixation System 4.5/8.5 Screw Caddy Base RIVA Posterior Fixation System 6.5 Screw Caddy Lid RIVA Posterior Fixation System Reduction Head Caddy Lid RIVA Posterior Fixation System Lordotic Rod Caddy Base RIVA Posterior Fixation System Specialty Head and Connector Caddy Base RIVA Posterior Fixation System 5.5 Cross Connector Caddy Base RIVA Posterior Fixation System 5.5 Screw Caddy Lid RIVA Posterior Fixation System 7.5 Screw Caddy Lid RIVA Posterior Fixation System Set Screw Caddy Base RIVA Posterior Fixation System 4.5/8.5 Screw Caddy Lid RIVA Posterior Fixation System Lordotic Rod Caddy Lid RIVA Posterior Fixation System 6.5 Screw Caddy Base RIVA Posterior Fixation System 5.5 Screw Caddy Base RIVA Posterior Fixation System 7.5 Screw Caddy Base RIVA Posterior Fixation System Standard Head Caddy Base RIVA Posterior Fixation System Set Screw Caddy Lid RIVA Posterior Fixation System Specialty Head and Connector Caddy Lid RIVA Posterior Fixation System Implant Set Top Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Top Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Bottom Level RIVA Posterior Fixation System Implant Set Bottom Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Lid RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Top Level RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Lid RIVA Posterior Fixation System Implant Tray Lid RIVA Posterior Fixation System Pedicle Screw Instrument Set 1 Base RIVA Posterior Fixation System Implant Tray Base RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Base RIVA Posterior Fixation System Pedicle Screw Instrument Set 2 Middle Level Xenix Medical RIVA Posterior Fixation System Rod Gripper RIVA Posterior Fixation System Distractor RIVA Posterior Fixation System Counter Torque - Long RIVA Posterior Fixation System Rod Rocker RIVA Posterior Fixation System Final Tightener - Short RIVA Posterior Fixation System Extended Tab Breaker, Tube RIVA Posterior Fixation System Counter Torque - Short RIVA Posterior Fixation System Axial Rod Reducer RIVA Posterior Fixation System Axial Reducer Driver RIVA Posterior Fixation System Axial Reducer Counter Torque RIVA Posterior Fixation System Final Tightener - Long RIVA Posterior Fixation System Screwdriver, Closed Head RIVA Posterior Fixation System Screwdriver, Standard RIVA Posterior Fixation System FINAL TIGHTENER, CROSSBAR RIVA Posterior Fixation System Screwdriver, Adjustable RIVA Posterior Fixation System Counter Torque RIVA Posterior Fixation System Final Tightener RIVA Posterior Fixation System Screwdriver, Reduction RIVA Posterior Fixation System COUNTER TORQUE, CROSSBAR RIVA Posterior Fixation System Extended Tab Remover, Plier RIVA Posterior Fixation System Rod Template, 200mm RIVA Posterior Fixation System Screw Measurement and Holder RIVA Posterior Fixation System Rod Template, 450mm RIVA Posterior Fixation System RIVA Posterior Fixation System Navigation Instruments LUX Expandable Lumbar Interbody System Ti3D Cervical neoWave LS NANOACTIV neoWave C RIVA Posterior Fixation System Cannulated Iliac Tap, 6.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 10.5mm RIVA Posterior Fixation System Pedicle Tap, 7.5mm RIVA Posterior Fixation System Pedicle Tap, 9.5mm RIVA Posterior Fixation System Iliac Tap, 11.5mm RIVA Posterior Fixation System Pedicle Tap, 5.5mm RIVA Posterior Fixation System Iliac Tap, 7.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 5.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 5.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 12.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 8.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 7.5mm RIVA Posterior Fixation System Iliac Tap, 12.5mm RIVA Posterior Fixation System Pedicle Tap, 3.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 4.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 11.5mm RIVA Posterior Fixation System Iliac Tap, 8.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 8.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 9.5mm RIVA Posterior Fixation System Iliac Tap, 9.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 12.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 8.5mm RIVA Posterior Fixation System Pedicle Tap, 10.5mm RIVA Posterior Fixation System Pedicle Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 7.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 8.5mm RIVA Posterior Fixation System Pedicle Tap, 8.5mm RIVA Posterior Fixation System Pedicle Tap, 4.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 9.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 10.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 10.5mm RIVA Posterior Fixation System Pedicle Tap, 11.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 4.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 10.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 3.5mm RIVA Posterior Fixation System Pedicle Tap, 12.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 11.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 12.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 7.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 11.5mm RIVA Posterior Fixation System Cannulated Pedicle Tap, 7.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 9.5mm RIVA Posterior Fixation System Cannulated Iliac Tap, 12.5mm RIVA Posterior Fixation System Iliac Tap, 10.5mm RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 11.5mm RIVA Posterior Fixation System Iliac Tap, 6.5mm RIVA Posterior Fixation System Awl-Tip Iliac Tap, 9.5mm RIVA Posterior Fixation System French Rod Bender RIVA Posterior Fixation System Compressor NeoFuse Ti3D neoWave C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-08-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-08-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-16
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2025-07-18
LYQ	Accessories, Fixation, Spinal Intervertebral Body	Orthopedic	Class 1	888.4540	2025-07-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-01-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-01-03
HTO	Reamer	Orthopedic	Class 1	888.4540	2025-07-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-01-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-07-18
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-07-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-12-08
HWT	Template	Orthopedic	Class 1	888.4800	2025-07-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-07-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-07-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-07-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-03-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-09-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-09-07
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2025-07-18
HXB	Probe	Orthopedic	Class 1	888.4540	2025-07-18
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2025-07-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-07-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-07-14

Official Correspondent

Ryan Phillips

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Xenix Medical

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
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012429289. Last updated year: 2026. Please use registration number 3012429289 when referencing this establishment in official correspondence.