FDA.reportPublic FDA data

Ti3D Cervical

Primary DI
00818345023819
Brand
Ti3D Cervical
Company
XENIX MEDICAL LLC
Model
B03-01
Catalog number
N/A
Device description
Cervical Inserter
Published
2022-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170318000
K222988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170318000NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC2017-07-12ODP
K222988000neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical2023-09-01ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345023819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345023819008183450238198183450238190818345023819

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-594-8633cs@xenixmedical.com

Regulatory Flags#

DUNS number
080386764
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493441634RIVA Pedicle Screw SystemFG1-A3-021922FG1-A3-0219222026-10-05
00840493441641LUX Expandable Interbody SystemLE1-A4-000560LE1-A4-0005602026-10-05
00840493441658LUX Expandable Interbody SystemLE1-A4-000570LE1-A4-0005702026-10-05
00840493441665RIVA Pedicle Screw SystemFG1-A1-000063FG1-A1-0000632026-10-05
00840493441672RIVA Pedicle Screw SystemFG1-A3-000081FG1-A3-0000812026-10-05
00840493441689RIVA Pedicle Screw SystemFG1-A3-000040FG1-A3-0000402026-10-05
00840493441696RIVA Pedicle Screw SystemFG1-A5-000013FG1-A5-0000132026-10-05
00840493441719RIVA Pedicle Screw SystemFG1-A1-000064FG1-A1-0000642026-10-05
00840493442020Xenix Medical Universal HandleUN1-H0-423005UN1-H0-4230052026-10-05
00840493442037Xenix Medical Universal HandleUN1-H0-423006UN1-H0-4230062026-10-05
00840493426426RIVA Pedicle Screw SystemFG1-16-302065FG1-16-3020652026-08-18
00840493426433RIVA Pedicle Screw SystemFG1-16-302070FG1-16-3020702026-08-18
00840493426440RIVA Pedicle Screw SystemFG1-16-302075FG1-16-3020752026-08-18
00840493426457RIVA Pedicle Screw SystemFG1-16-302080FG1-16-3020802026-08-18
00840493426464RIVA Pedicle Screw SystemFG1-16-302085FG1-16-3020852026-08-18
00840493426471RIVA Pedicle Screw SystemFG1-16-302090FG1-16-3020902026-08-18
00840493426488RIVA Pedicle Screw SystemFG1-16-302095FG1-16-3020952026-08-18
00840493426495RIVA Pedicle Screw SystemFG1-16-302100FG1-16-3021002026-08-18
00840493426501RIVA Pedicle Screw SystemFG1-16-302110FG1-16-3021102026-08-18
00840493426518RIVA Pedicle Screw SystemFG1-16-302120FG1-16-3021202026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
00842078100219HammerFiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100479IO FiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100486XMCPEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
04250337122432iLESSYS® Interlaminar Endoscopic Surgical SystemJoimax GmbHLXH2026-10-29
07630699700689Knee InstrumentsMedacta International SALXH2026-10-29
08800017276182LOSPACorentec Co., LtdLXH2026-10-29
08806373878039LOSPACorentec Co., LtdLXH2026-10-29
08806373889653LOSPACorentec Co., LtdLXH2026-10-29
08806373894190LOSPACorentec Co., LtdLXH2026-10-29
10850070500101Core Wire, Removal Tool, ReusableCURVAFIX, INC.LXH2026-10-29
10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28