FDA.reportPublic FDA data

PLS

Primary DI
08033726405462
Brand
PLS
Company
SINTEA PLUSTEK SRL
Model
  PLS-47T52
Published
2015-09-08
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
K060513000
K081631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060513000SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.XSintea Biotech, Inc.2006-03-10KWP
K081631000SINTEA BIOTECH PLS MULTI-AXIAL SCREWSSintea Biotech, Inc.2008-07-18MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033726405462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033726405462080337264054628033726405462

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
M711620155550Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155600Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155650Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155700Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155750Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155800Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155850Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
10888857598256Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598461Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598478Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24