FDA.reportPublic FDA data

PERLA ® TL

Primary DI
07640450867674
Brand
PERLA ® TL
Company
SpineArt SA
Model
TLF-PC OO OF-S
Catalog number
TLF-PC OO OF-S
Device description
ROD CONNECTOR PARALLEL OPEN/OPEN OFFSET
Published
2021-01-06
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203222000PERLA TL Posterior Osteosynthesis SystemSpineart2020-12-17NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640450867674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640450867674076404508676747640450867674

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
M719GL3110TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GLC403S0TiLockGenesys Orthopedics Systems LLCNKB2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCNKB2026-08-03
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28