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AccuStride System MC-3D132

by Medcad

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 22 Oct 2026

Documents

510(k) K241811

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810007633282 UDI-DI Date30 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241811 Date13 Mar 2025DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AccuStride System
Generic name
Custom-made orthopaedic/craniofacial surgical guide
Model / Ref / Catalog
MC-3D132
Primary DI / UDI-DI
00810007633282
510(k) Number
FDA product code
PBF
GMDN term
Custom-made orthopaedic/craniofacial surgical guide
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Custom-made orthopaedic/craniofacial surgical guide

Cleared under the same submission (K241811)

Other devices from Medcad

See all devices from Medcad →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date

Other properties (9)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Manufacturing date: No