FDA.reportPublic FDA data

PERLA ®

Primary DI
07640185341517
Brand
PERLA ®
Company
SpineArt SA
Model
CPF-PS 45 08-S
Catalog number
CPF-PS 45 08-S
Device description
POLYAXIAL SCREW
Published
2019-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190071000Perla® Posterior Cervico-Thoracic Fixation SystemSpineart2019-02-25NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640185341517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640185341517076401853415177640185341517

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483016148
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640221370846SCALASLA-BX 20 00-N2026-07-24
07640221370853SCALASLA-BX 20 01-N2026-07-24
07640221370860SCALASLA-BX 20 02-N2026-07-24
07640221373663SCALASLA-IN 01 01-N2026-07-24
07640221373670SCALASLA-IN 01 02-N2026-07-24
07640221373687SCALASLA-IN 02 00-N2026-07-24
07640221373694SCALASLA-IN 03 01-N2026-07-24
07640221373700SCALASLA-IN 03 02-N2026-07-24
07640221373717SCALASLA-IN 04 01-N2026-07-24
07640221373724SCALASLA-IN 04 02-N2026-07-24
07640221373731SCALASLA-IN 04 03-N2026-07-24
07640221373748SCALASLA-IN 05 01-N2026-07-24
07640221373755SCALASLA-IN 05 02-N2026-07-24
07640221373762SCALASLA-IN 05 03-N2026-07-24
07640221373779SCALASLA-IN 06 01-N2026-07-24
07640221373786SCALASLA-IN 06 02-N2026-07-24
07640221373793SCALASLA-IN 06 03-N2026-07-24
07640332476345PERLA ®NAV-IN BR 00-NNAV-IN BR 00-N2025-11-20
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992330INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992347INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992453INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00840606192057Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192064Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192071Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192088Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192095Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192101Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192118Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192125Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192132Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192149Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192156Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192163Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192170Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192187Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192194Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192200Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192217Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192224Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192231Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192248Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192255Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192262Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192279Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192286Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192293Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24