FDA.reportPublic FDA data

SOLACE Sacroiliac Fixation System

Primary DI
00818345029231
Brand
SOLACE Sacroiliac Fixation System
Company
XENIX MEDICAL LLC
Model
SS1-A2-000560
Catalog number
SS1-A2-000560
Device description
Targeting Pin Guide 60mm
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
00818345029231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029231008183450292318183450292310818345029231

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
00840493425559RIVA Pedicle Screw SystemFG1-15-300600FG1-15-3006002026-08-03
00840493425566RIVA Pedicle Screw SystemFG1-16-300025FG1-16-3000252026-08-03
00840493425573RIVA Pedicle Screw SystemFG1-16-300030FG1-16-3000302026-08-03
00840493425580RIVA Pedicle Screw SystemFG1-16-300035FG1-16-3000352026-08-03
00840493425597RIVA Pedicle Screw SystemFG1-16-300040FG1-16-3000402026-08-03
00840493425603RIVA Pedicle Screw SystemFG1-16-300045FG1-16-3000452026-08-03
00840493425610RIVA Pedicle Screw SystemFG1-16-300050FG1-16-3000502026-08-03
00840493425627RIVA Pedicle Screw SystemFG1-16-300055FG1-16-3000552026-08-03
00840493425634RIVA Pedicle Screw SystemFG1-16-300060FG1-16-3000602026-08-03
00840493425641RIVA Pedicle Screw SystemFG1-16-300065FG1-16-3000652026-08-03
00840493425658RIVA Pedicle Screw SystemFG1-16-300070FG1-16-3000702026-08-03
00840493425665RIVA Pedicle Screw SystemFG1-16-300075FG1-16-3000752026-08-03
00840493425672RIVA Pedicle Screw SystemFG1-16-300080FG1-16-3000802026-08-03
00840493425689RIVA Pedicle Screw SystemFG1-16-300085FG1-16-3000852026-08-03
00840493425696RIVA Pedicle Screw SystemFG1-16-300090FG1-16-3000902026-08-03
00840493425702RIVA Pedicle Screw SystemFG1-16-300095FG1-16-3000952026-08-03
00840493425719RIVA Pedicle Screw SystemFG1-16-300100FG1-16-3001002026-08-03
00840493425726RIVA Pedicle Screw SystemFG1-16-300110FG1-16-3001102026-08-03
00840493425382RIVA Pedicle Screw SystemFG1-15-300085FG1-15-3000852026-07-28
00840493425399RIVA Pedicle Screw SystemFG1-15-300090FG1-15-3000902026-07-28

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00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
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00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
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