FDA.reportPublic FDA data

PERLA ® TL

Primary DI
07640221372970
Brand
PERLA ® TL
Company
SpineArt SA
Model
TLF-RC UU 00-S
Device description
ARTICULATED ROD CONNECTOR, W-SHAPE OPEN/OPEN
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K253966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253966000PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2026-05-01NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640221372970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640221372970076402213729707640221372970

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
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
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCNKB2026-08-18