FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00818345029873
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A3-000010
Catalog number
FG1-A3-000010
Device description
Screwdriver, Adjustable
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00818345029873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029873008183450298738183450298730818345029873

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26