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CORUS PCSS 3D LevelOne, 4mm DX-50-413

by Providence Medical Technology

CORUS PCSS 3D LevelOne, 4mm DX-50-413 is a device classified as Unclassified made by Providence Medical Technology, cleared under FDA 510(k) K253676 on 14 May 2026 and listed in FDA GUDID since 30 Sep 2026 (UDI-DI 00852776006614), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

510(k) K253676

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852776006614 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253676 Date14 May 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253676 decided 14 May 2026 Active
  • FDA GUDID UDI-DI 00852776006614 listed 30 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253676
  2. Listed FDA GUDID 00852776006614

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CORUS PCSS 3D LevelOne, 4mm
Generic name
Internal spinal fixation procedure kit, single-use
Model / reference
DX-50-413
Primary DI / UDI-DI
00852776006614
510(k) Number
FDA product code
MRW
GMDN term
Internal spinal fixation procedure kit, single-use
Device class
U
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K253676)

and 1 more cleared under K253676

Other devices from Providence Medical Technology

See all devices from Providence Medical Technology →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)