FDA.reportPublic FDA data

neoWave LS

Primary DI
00818345027077
Brand
neoWave LS
Company
XENIX MEDICAL LLC
Model
23-K01-A0213
Catalog number
N/A
Device description
DISTRACTOR, Dr. Abel, 13MM
Published
2021-12-30
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
K182210000
K222988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182210000TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC2019-01-07MAX
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
00818345027077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345027077008183450270778183450270770818345027077

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. 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
00840493422596RIVA Pedicle Screw SystemFG1-16-200200FG1-16-2002002026-06-05
00840493422602RIVA Pedicle Screw SystemFG1-16-200250FG1-16-2002502026-06-05
00840493422619RIVA Pedicle Screw SystemFG1-16-200300FG1-16-2003002026-06-05
00840493422626RIVA Pedicle Screw SystemFG1-16-200350FG1-16-2003502026-06-05
00840493422633RIVA Pedicle Screw SystemFG1-16-200400FG1-16-2004002026-06-05
00840493422640RIVA Pedicle Screw SystemFG1-16-200450FG1-16-2004502026-06-05
00840493422657RIVA Pedicle Screw SystemFG1-16-200500FG1-16-2005002026-06-05
00840493422664RIVA Pedicle Screw SystemFG1-16-200550FG1-16-2005502026-06-05
00840493422671RIVA Pedicle Screw SystemFG1-16-200600FG1-16-2006002026-06-05
00840493422688RIVA Pedicle Screw SystemFG1-15-201200FG1-15-2012002026-06-05
00840493422695RIVA Pedicle Screw SystemFG1-15-201250FG1-15-2012502026-06-05
00840493422701RIVA Pedicle Screw SystemFG1-15-201300FG1-15-2013002026-06-05
00840493422718RIVA Pedicle Screw SystemFG1-15-201350FG1-15-2013502026-06-05
00840493422725RIVA Pedicle Screw SystemFG1-15-201400FG1-15-2014002026-06-05
00840493422732RIVA Pedicle Screw SystemFG1-15-201450FG1-15-2014502026-06-05
00840493422749RIVA Pedicle Screw SystemFG1-15-201500FG1-15-2015002026-06-05
00840493422756RIVA Pedicle Screw SystemFG1-15-201550FG1-15-2015502026-06-05
00840493422763RIVA Pedicle Screw SystemFG1-15-201600FG1-15-2016002026-06-05
00840493422770RIVA Pedicle Screw SystemFG1-16-201200FG1-16-2012002026-06-05
00840493422787RIVA Pedicle Screw SystemFG1-16-201250FG1-16-2012502026-06-05

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Primary DI, Brand, Company table
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00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
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08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
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07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
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00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
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