FDA.reportPublic FDA data

SOLACE Sacroiliac Fixation System

Primary DI
00818345029514
Brand
SOLACE Sacroiliac Fixation System
Company
XENIX MEDICAL LLC
Model
SS1-A1-000090
Catalog number
SS1-A1-000090
Device description
Measuring Dilator, 10.5mm
Published
2025-02-05
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
HWCScrew, Fixation, Bone
OLOOrthopedic Stereotaxic Instrument
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231829000Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical2023-08-15OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345029514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029514008183450295148183450295140818345029514

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. 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
00840493423166RIVA Pedicle Screw SystemFG1-16-202025FG1-16-2020252026-06-08
00840493423173RIVA Pedicle Screw SystemFG1-16-202030FG1-16-2020302026-06-08
00840493423180RIVA Pedicle Screw SystemFG1-16-202035FG1-16-2020352026-06-08
00840493423197RIVA Pedicle Screw SystemFG1-16-202040FG1-16-2020402026-06-08
00840493423203RIVA Pedicle Screw SystemFG1-16-202045FG1-16-2020452026-06-08
00840493423210RIVA Pedicle Screw SystemFG1-16-202050FG1-16-2020502026-06-08
00840493423227RIVA Pedicle Screw SystemFG1-16-202055FG1-16-2020552026-06-08
00840493423234RIVA Pedicle Screw SystemFG1-16-202060FG1-16-2020602026-06-08
00840493423241RIVA Pedicle Screw SystemFG1-16-202065FG1-16-2020652026-06-08
00840493423258RIVA Pedicle Screw SystemFG1-16-202070FG1-16-2020702026-06-08
00840493423265RIVA Pedicle Screw SystemFG1-16-202075FG1-16-2020752026-06-08
00840493423272RIVA Pedicle Screw SystemFG1-16-202080FG1-16-2020802026-06-08
00840493423289RIVA Pedicle Screw SystemFG1-16-202085FG1-16-2020852026-06-08
00840493423296RIVA Pedicle Screw SystemFG1-16-202090FG1-16-2020902026-06-08
00840493423302RIVA Pedicle Screw SystemFG1-16-202095FG1-16-2020952026-06-08
00840493423319RIVA Pedicle Screw SystemFG1-16-202100FG1-16-2021002026-06-08
00840493423326RIVA Pedicle Screw SystemFG1-16-202110FG1-16-2021102026-06-08
00840493423333RIVA Pedicle Screw SystemFG1-16-202120FG1-16-2021202026-06-08
00840493423340RIVA Pedicle Screw SystemFG1-16-202130FG1-16-2021302026-06-08
00840493423357RIVA Pedicle Screw SystemFG1-16-202140FG1-16-2021402026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08