FDA.reportPublic FDA data

SOLACE Sacroiliac Fixation System

Primary DI
00840493415031
Brand
SOLACE Sacroiliac Fixation System
Company
XENIX MEDICAL LLC
Model
SS1-B0-000130
Catalog number
SS1-B0-000130
Device description
SI Tray Graft Luer Caddy Base
Published
2025-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840493415031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493415031008404934150318404934150310840493415031

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080386764
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493418704RIVA Pedicle Screw SystemFG1-15-0120110FG1-15-01201102026-03-24
00840493418711RIVA Pedicle Screw SystemFG1-15-0120120FG1-15-01201202026-03-24
00840493418728RIVA Pedicle Screw SystemFG1-15-0120130FG1-15-01201302026-03-24
00840493418735RIVA Pedicle Screw SystemFG1-15-0120140FG1-15-01201402026-03-24
00840493418742RIVA Pedicle Screw SystemFG1-15-0120150FG1-15-01201502026-03-24
00840493418759RIVA Pedicle Screw SystemFG1-16-0120025FG1-16-01200252026-03-24
00840493418766RIVA Pedicle Screw SystemFG1-16-0120030FG1-16-01200302026-03-24
00840493418773RIVA Pedicle Screw SystemFG1-16-0120035FG1-16-01200352026-03-24
00840493418780RIVA Pedicle Screw SystemFG1-16-0120040FG1-16-01200402026-03-24
00840493418797RIVA Pedicle Screw SystemFG1-16-0120045FG1-16-01200452026-03-24
00840493418803RIVA Pedicle Screw SystemFG1-16-0120050FG1-16-01200502026-03-24
00840493418810RIVA Pedicle Screw SystemFG1-16-0120055FG1-16-01200552026-03-24
00840493418827RIVA Pedicle Screw SystemFG1-16-0120060FG1-16-01200602026-03-24
00840493418834RIVA Pedicle Screw SystemFG1-16-0120065FG1-16-01200652026-03-24
00840493418841RIVA Pedicle Screw SystemFG1-16-0120070FG1-16-01200702026-03-24
00840493418858RIVA Pedicle Screw SystemFG1-16-0120075FG1-16-01200752026-03-24
00840493418865RIVA Pedicle Screw SystemFG1-16-0120080FG1-16-01200802026-03-24
00840493418872RIVA Pedicle Screw SystemFG1-16-0120085FG1-16-01200852026-03-24
00840493418889RIVA Pedicle Screw SystemFG1-16-0120090FG1-16-01200902026-03-24
00840493418896RIVA Pedicle Screw SystemFG1-16-0120095FG1-16-01200952026-03-24

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00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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