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Curve Navigation 17700

by Brainlab SE

Ref 17701, 17702

Curve Navigation 17700 (17701) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K262257 on 30 Sep 2026 (6 earlier submissions), registered in EUDAMED on 16 Jul 2025 (Basic UDI-DI 4056481PlatformsMR) and listed in FDA GUDID since 22 May 2023 (UDI-DI 04056481144500), active as of 23 Oct 2026.

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

CE MDR 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) K262257

+6 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK262257 Date30 Sep 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number4056481PlatformsMR Basic UDI-DI Date16 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481144500 UDI-DI Date22 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K262257 decided 30 Sep 2026 Active· +6 more in the status table
  • EUDAMED Basic UDI-DI 4056481PlatformsMR registered 16 Jul 2025 Active
  • FDA GUDID UDI-DI 04056481144500 listed 22 May 2023 Listed

Timeline

9 dated events

  1. Cleared FDA 510(k) K221618
  2. Cleared FDA 510(k) K213989
  3. Cleared FDA 510(k) K223734
  4. Listed FDA GUDID 04056481144500
  5. Cleared FDA 510(k) K223288
  6. Cleared FDA 510(k) K223864
  7. Cleared FDA 510(k) K243698
  8. Registered EUDAMED 4056481PlatformsMR
  9. Cleared FDA 510(k) K262257

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Curve Navigation 17700
Curve Navigation
Generic name
Electromagnetic/optical surgical navigation/tracking system
Model / reference
17701, 17702
Primary DI / UDI-DI
04056481144500, 04056481146702
Basic UDI-DI
4056481PlatformsMR, 4056481CurveNavigationEB
510(k) Number
FDA product code
HAW, PGW, OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)