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Conflow Bone Cement 110043025

by Tecres

Conflow Bone Cement 110043025 is a Class II device made by Tecres, cleared under FDA 510(k) K021715 on 12 Jun 2002 and listed in FDA GUDID since 9 Jun 2021 (UDI-DI 08031497002095), active as of 9 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 9 Nov 2026

Documents

510(k) K021715

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08031497002095 UDI-DI Date9 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK021715 Date12 Jun 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K021715 decided 12 Jun 2002 Active
  • FDA GUDID UDI-DI 08031497002095 listed 9 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K021715
  2. Listed FDA GUDID 08031497002095

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Conflow Bone Cement
Generic name
Orthopaedic cement, non-antimicrobial
Model / reference
110043025
Primary DI / UDI-DI
08031497002095
510(k) Number
FDA product code
LOD
GMDN term
Orthopaedic cement, non-antimicrobial
Device class
Class II
Regulation number
888.3027
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)