FDA.reportPublic FDA data

CONDUIT SYNFIX Evolution

Primary DI
00190776386825
Brand
CONDUIT SYNFIX Evolution
Company
Avalign Technologies, Inc.
Model
440300001
Device description
Locking Key
Published
2025-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776386825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776386825001907763868251907763868250190776386825

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, single-useA sterile hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776433000Millennium1-161962026-10-26
00190776437060Millennium1-121219-122026-10-26
00190776437077Millennium1-410324C2026-10-26
00190776437084Millennium1-516410-6752026-10-26
00190776437091Millennium1-516420-6752026-10-26
00190776437107Millennium1-516430-6752026-10-26
00190776437114Millennium1-516440-6752026-10-26
00190776437121Millennium1-516450-6752026-10-26
00190776437138Millennium1-516460-6752026-10-26
00190776437145Millennium1-508001H2026-10-26
00190776437152Millennium1-508002H2026-10-26
00190776437169Millennium1-508003H2026-10-26
00190776439743Millenium85-710191572026-10-26
00190776439750Millenium85-650112602026-10-26
00190776439767Millenium85-650112642026-10-26
00190776439774Millenium85-250039002026-10-26
00190776439781Millenium85-530183372026-10-26
00190776439798Millenium85-200803072026-10-26
00190776439804Millenium85-200803122026-10-26
00190776436902Millennium1-5053602026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.OVD2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.OVD2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.OVD2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.OVD2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.OVD2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.OVD2026-10-23
00840606187626Ventana ASPINAL ELEMENTS, INC.OVD2026-10-22
10889981217204MeridianSeaspine Orthopedics CorporationOVD2022-08-25
10889981230906RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230913RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230920RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230937RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230944RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230951RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230968RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230975RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230982RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230999RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231002RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231019RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231026RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231033RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231248RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231255RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231262RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214401MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214418MeridianSeaspine Orthopedics CorporationOVD2020-12-30