FDA.reportPublic FDA data

ACP

Primary DI
08033726409842
Brand
ACP
Company
SINTEA PLUSTEK SRL
Model
ACP-10T510
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
08033726409842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033726409842080337264098428033726409842

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

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
08033726407176ACPACP-14T522015-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536162109neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGKWP2026-06-08
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082055ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082062ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082079ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082086ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082093ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
M711BTA2020Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
M711LS7490Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-06-05
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04