Skip to content

Perla ® Tl Tlf-5S C5 50-S

by Spineart

Ref TLF-5S C5 50-S

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07640185346840 Basic UDI-DI 07640185346840UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640185346840 UDI-DI Date13 Feb 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Perla ® Tl
Generic Name
Bone-screw internal spinal fixation system, sterile
Device Name
Perla® Tl - Posterior Thoraco-Lumbar Fixation System Cocr Rod
Model / Ref / Catalog
TLF-5S C5 50-S
Description
STRAIGHT ROD HEXA COBALT CHROMIUM Ø5.5 L550
Primary DI / UDI-DI
07640185346840
Basic UDI-DI
B-07640185346840
FDA Product Code
KWP, NKB
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system, sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3050, 888.3070
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5.5 Millimeter
Length — 550 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Bone-screw internal spinal fixation system, sterile

Other devices from Spineart

See all devices from Spineart →

Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No