FDA.reportPublic FDA data

ShurFit ACIF Systems

Primary DI
00840019908030
Brand
ShurFit ACIF Systems
Company
PRECISION SPINE, INC.
Model
45-CP-1006
Catalog number
45-CP-1006
Device description
10° X 6mm Implant
Published
2019-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083118000SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICESpinal USA2009-05-27ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019908030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019908030008400199080308400199080300840019908030

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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 included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019970907MD-Vue™ Lateral Access System54-TA-050054-TA-05002026-05-01
00840019970914MD-Vue™ Lateral Access System54-TA-060054-TA-06002026-05-01
00840019970921MD-Vue™ Lateral Access System54-TA-070054-TA-07002026-05-01
00840019970938MD-Vue™ Lateral Access System54-TA-080054-TA-08002026-05-01
00840019970945MD-Vue™ Lateral Access System54-TA-090054-TA-09002026-05-01
00840019970952MD-Vue™ Lateral Access System54-TA-100054-TA-10002026-05-01
00840019971133Reform Ti Modular39-SF-654539-SF-65452026-01-13
00840019971140Reform Ti Modular39-SF-655039-SF-65502026-01-13
00840019971157Reform Ti Modular39-SF-655539-SF-65552026-01-13
00840019971164Reform Ti Modular39-SF-656039-SF-65602026-01-13
00840019971171Reform Ti Modular39-SF-753039-SF-75302026-01-13
00840019971188Reform Ti Modular39-SF-753539-SF-75352026-01-13
00840019971195Reform Ti Modular39-SF-754039-SF-75402026-01-13
00840019971201Reform Ti Modular39-SF-754539-SF-75452026-01-13
00840019971218Reform Ti Modular39-SF-755039-SF-75502026-01-13
00840019971225Reform Ti Modular39-SF-755539-SF-75552026-01-13
00840019971232Reform Ti Modular39-SF-756039-SF-75602026-01-13
00840019971249Reform Ti Modular39-SF-757039-SF-75702026-01-13
00840019971256Reform Ti Modular39-SF-758039-SF-75802026-01-13
00840019971263Reform Ti Modular39-SF-853539-SF-85352026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370419SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370464SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370471SCARLET® AC-TiSpineArt SAODP2025-11-10
07640164849645icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2025-06-02
07640164849652icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2025-06-02
07640164849669icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2025-06-02
07640164849676icotec Cervical Cage, Cervical Cage Anatomic, Container Rackicotec AGODP2025-06-02
07640332477991SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478004SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478011SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332477984SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478684SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478691SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478707SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478714SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478721SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478738SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478745SCARLET® AC-TiSpineArt SAODP2024-08-02
07640172551400icotec Cervical Cage, Inserter Sleeve, longicotec AGODP2021-09-01
07640172551417icotec Cervical Cage, Inserter Rod, longicotec AGODP2021-09-01
07640185341760SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341784SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341807SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341746SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-07
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16
07640140433806icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2018-07-16
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07640140433820icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mmicotec AGODP2018-07-16