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
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
07640221370594BAGUERA® CCDP-IN SM 06-N2026-08-19
07640221370600BAGUERA® CCDP-IN ME 06-N2026-08-19
07640221370617BAGUERA® CCDP-IN LA 06-N2026-08-19
07640221370624BAGUERA® CCDP-IN 00 08-N2026-08-19
07640221370631BAGUERA® CCDP-BX 20 01-N2026-08-19
07640221370648BAGUERA® CCDP-BX 20 02-N2026-08-19
07640221370655BAGUERA® CLID-BX 16 00-N2026-08-19
07640221370877BAGUERA® CCDP-BX 10 03-N2026-08-19
07640332471623PERLA TL NAVNAV-IN 51 31-NNAV-IN 51 31-N2025-11-20
07640332476338PERLA ®AST-IN EC 00-NAST-IN EC 00-N2025-11-20
07640221370846SCALASLA-BX 20 00-N2026-07-24
07640221370853SCALASLA-BX 20 01-N2026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982239862CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239886CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239909CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239923CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239947CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982239961CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240240CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240363CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982240622CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450151CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450168CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450175CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450182CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982450199CREOGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521134QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521134QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.KWP2026-08-14