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Perla ® Cpf-or Cs 90-S

by Spineart

Ref CPF-OR CS 90-S

Perla ® Cpf-or Cs 90-S is a device classified as Class IIb in the EU and Class II in the US made by Spineart, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-07640185348127) and listed in FDA GUDID since 19 May 2020 (UDI-DI 07640185348127), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07640185348127 Basic UDI-DI 07640185348127UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640185348127 UDI-DI Date19 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07640185348127 registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 07640185348127 listed 19 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640185348127
  2. Registered EUDAMED B-07640185348127

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  • Withdrawn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 ®
Generic name
Bone-screw internal spinal fixation system rod
Device name
Perla® - Posterior Oct Fixation System Cocr Rod
Model / Ref / Catalog
CPF-OR CS 90-S
Primary DI / UDI-DI
07640185348127
Basic UDI-DI
B-07640185348127
FDA product code
NKG, KWP
EMDN code
P09070302 Thoracolumbosacral fixation systems
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3075, 888.3050
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Angle — 90 degree

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone-screw internal spinal fixation system rod

Similar devices in this category

Other devices filed under THORACOLUMBOSACRAL FIXATION SYSTEMS.

Other devices from Spineart

See all devices from Spineart →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)