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Accuris 71236412

by Smith & Nephew, Inc.

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 23 Oct 2026

Documents

510(k) K113038

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03596010477033 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113038 Date5 Jan 2012DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
Accuris
Generic name
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
71236412
Description
ACCURIS-TIBIA INSRT TRIAL MEDIUM/LARGE 12
Primary DI / UDI-DI
03596010477033
510(k) Number
FDA product code
HSX
GMDN term
Uncoated knee tibia prosthesis, polyethylene
Device class
Class II
Regulation number
888.3520
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Uncoated knee tibia prosthesis, polyethylene

Cleared under the same submission (K113038)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (11)

  • Supplied sterile: No
  • Single use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No