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Halo System Component 1208-83

by Pmt Corp.

Ref 1201-18L, 1208-83

Halo System Component 1208-83 is a device classified as Class IIb in the EU and Class II in the US made by Pmt Corp., registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI B-10650551093081), cleared under FDA 510(k) K090733 on 28 Jul 2009 and listed in FDA GUDID since 10 Mar 2025 (UDI-DI 10650551093081), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090733

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10650551093081 Basic UDI-DI Date15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10650551093081 UDI-DI Date10 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK090733 Date28 Jul 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10650551093081 registered 15 Jun 2026 Active
  • FDA 510(k) K090733 decided 28 Jul 2009 Active
  • FDA GUDID UDI-DI 10650551093081 listed 10 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090733
  2. Listed FDA GUDID 10650551093081
  3. Registered EUDAMED B-10650551093081

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Halo System Component
Pmt® Corporation Halo
Generic name
Cervical spine immobilization system, single-use
Model / Ref / Catalog
1208-83, 1201-18L
Primary DI / UDI-DI
10650551093081, 10650551117060, 00650551117063
Basic UDI-DI
B-10650551093081, B-10650551117060
510(k) Number
FDA product code
HAX
EMDN code
P09070301 Cervical fixation systems
GMDN term
Cervical spine immobilization system, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.5960
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 18 Inch

Truth per registry

2 sources · 2 fields differ

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

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: Cervical spine immobilization system, single-use

Cleared under the same submission (K090733)

and 8 more cleared under K090733

Similar devices in this category

Other devices filed under CERVICAL FIXATION SYSTEMS.

Other devices from Pmt Corp.

See all devices from Pmt Corp. →

Properties

  • Supplied sterile YesEUDAMEDGUDIDNoEUDAMEDGUDID
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date YesGUDIDNoGUDID
  • Manufacturing date YesGUDIDNoGUDID
Other properties (16, all answered No)