FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00818345029811
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A3-000074
Catalog number
FG1-A3-000074
Device description
Rod Template, 450mm
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345029811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029811008183450298118183450298110818345029811

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840493426525RIVA Pedicle Screw SystemFG1-16-302130FG1-16-3021302026-08-18
00840493426532RIVA Pedicle Screw SystemFG1-16-302140FG1-16-3021402026-08-18
00840493426549RIVA Pedicle Screw SystemFG1-16-302150FG1-16-3021502026-08-18
00840493426556RIVA Pedicle Screw SystemFG1-16-302200FG1-16-3022002026-08-18
00840493426563RIVA Pedicle Screw SystemFG1-16-302250FG1-16-3022502026-08-18
00840493426570RIVA Pedicle Screw SystemFG1-16-302300FG1-16-3023002026-08-18
00840493426587RIVA Pedicle Screw SystemFG1-16-302350FG1-16-3023502026-08-18
00840493426594RIVA Pedicle Screw SystemFG1-16-302400FG1-16-3024002026-08-18
00840493426600RIVA Pedicle Screw SystemFG1-16-302450FG1-16-3024502026-08-18
00840493426617RIVA Pedicle Screw SystemFG1-16-302500FG1-16-3025002026-08-18

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Primary DI, Brand, Company table
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