FDA.reportPublic FDA data

ACP

Primary DI
08033726407176
Brand
ACP
Company
SINTEA PLUSTEK SRL
Model
ACP-14T52
Published
2015-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041989000SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.XSintea Biotech, Inc.2004-09-16KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033726407176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033726407176080337264071768033726407176

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
544150399
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033726407091ACPACP-14T512015-10-06
08033726407107ACPACP-14T51P2015-10-06
08033726407114ACPACP-16T512015-10-06
08033726407121ACPACP-16T51P2015-10-06
08033726407138ACPACP-18T512015-10-06
08033726407145ACPACP-18T51P2015-10-06
08033726407152ACPACP-20T512015-10-06
08033726407169ACPACP-20T51P2015-10-06
08033726407183ACPACP-16T522015-10-06
08033726407190ACPACP-18T522015-10-06
08033726407206ACPACP-20T522015-10-06
08033726407213ACPACP-14T532015-10-06
08033726407220ACPACP-16T532015-10-06
08033726407237ACPACP-18T532015-10-06
08033726407244ACPACP-20T532015-10-06
08033726407251ACPACP-14T542015-10-06
08033726407268ACPACP-16T542015-10-06
08033726407275ACPACP-18T542015-10-06
08033726407282ACPACP-20T542015-10-06
08033726409439ACPACP-01T5142015-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613154111725OASYSStryker CorporationKWP2015-09-14
07613154129867OASYSStryker CorporationKWP2015-09-14
07613154170142OASYSStryker CorporationKWP2015-09-14
07613154170166OASYSStryker CorporationKWP2015-09-14
07613154345014MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345021MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345038MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345045MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345052MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345069MAC TITANIUMStryker CorporationKWP2015-09-14
07613154345090MAC TITANIUMStryker CorporationKWP2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08
07613153045861XIA IIStryker CorporationKWP2014-12-08
07613153045878XIA IIStryker CorporationKWP2014-12-08
07613153045885XIA IIStryker CorporationKWP2014-12-08
07613153045892XIA IIStryker CorporationKWP2014-12-08
07613153045908XIA IIStryker CorporationKWP2014-12-08
07613153045915XIA IIStryker CorporationKWP2014-12-08