FDA.reportPublic FDA data

PERLA ®

Primary DI
07640185349995
Brand
PERLA ®
Company
SpineArt SA
Model
CPF-IN 54 00-N
Catalog number
CPF-IN 54 00-N
Device description
OCCIPITAL PLATE HOLDER
Published
2020-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200571000PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart2020-05-01NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640185349995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640185349995076401853499957640185349995

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640139343185BAGUERA C INSTRUMENTATIONCDP-IN 30 01-N2026-08-27
07640221370884TRYPTIK® TiTRY-BX 40 01-N2026-08-27
07640178972452ROMEO posterior osteosynthesis systemNAV-IN 01 00-NNAV-IN 01 00-N2019-01-31
07640221370891BAGUERA® CBAG-CT 13 05-S2026-08-21
07640221370907BAGUERA® CBAG-CT 13 06-S2026-08-21
07640221370914BAGUERA® CBAG-CT 13 07-S2026-08-21
07640221370921BAGUERA® CBAG-CT 14 05-S2026-08-21
07640221370938BAGUERA® CBAG-CT 14 06-S2026-08-21
07640221370945BAGUERA® CBAG-CT 14 07-S2026-08-21
07640221370952BAGUERA® CBAG-CT 16 05-S2026-08-21
07640221370969BAGUERA® CBAG-CT 16 06-S2026-08-21
07640221370976BAGUERA® CBAG-CT 16 07-S2026-08-21
07640139343079BAGUERA® CCDP-IN 00 03-N2026-08-19
07640221370525BAGUERA® CCDP-IN 00 07-N2026-08-19
07640221370532BAGUERA® CCDP-IN 00 06-N2026-08-19
07640221370549BAGUERA® CCDP-IN 61 00-N2026-08-19
07640221370556BAGUERA® CCDP-IN 60 01-N2026-08-19
07640221370563BAGUERA® CCDP-IN SM 05-N2026-08-19
07640221370570BAGUERA® CCDP-IN ME 05-N2026-08-19
07640221370587BAGUERA® CCDP-IN LA 05-N2026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693100VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693117VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693124VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693131VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693148VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693155VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693162VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
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