FDA.reportPublic FDA data

aprevo

Primary DI
00810056992958
Brand
aprevo
Company
Carlsmed, Inc.
Model
1098.20.2
Device description
aprevo®, ACDF-X Locking Screw, Ø3.5x20mm / 2 PK
Published
2026-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242260000
K252894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242260000aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.2024-11-15ODP
K252894000aprevo® cervical interbody systemCarlsmed, Inc.2026-01-06ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810056992958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810056992958008100569929588100569929580810056992958

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117449452
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810056995638corra1421.20.22026-08-17
00810056992743aprevo1098.13.22026-03-17
00810056992804aprevo1098.15.22026-03-17
00810056992866aprevo1098.17.22026-03-17
00810056995430corra1426.18.32026-03-11
00081005699543corra1426.18.32026-02-04
00810056993092corra16102026-01-31
00810056993108corra16162026-01-30
00810056993122corra1550.27.142026-01-30
00810056993139corra15602026-01-30
00810056993146corra16202026-01-30
00810056993153corra1550.22.122026-01-30
00810056993160corra1550.22.142026-01-30
00810056993177corra1550.22.162026-01-30
00810056993184corra1550.22.182026-01-30
00810056993191corra1550.22.202026-01-30
00810056993207corra1550.27.122026-01-30
00810056993214corra1550.27.162026-01-30
00810056993221corra1550.27.182026-01-30
00810056993238corra1550.27.202026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322776391QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776407QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776414QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776421QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776438QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776445QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776452QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776469QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776476QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776483QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776490QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776506QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776513QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776520QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776537QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776544QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776551QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776568QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776575QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776582QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776599QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776605QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776612QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776629QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776636QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776643QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776650QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776667QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776674QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18
08800322776681QUASAR Standalone ACIF SystemGS Medical Co., Ltd.OVE2026-09-18