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Trel-X Putty TXP05

by Integra Lifesciences Corp.

Trel-X Putty TXP05 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K040419 on 25 Mar 2005 and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780112471), active as of 23 Oct 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 23 Oct 2026

Documents

510(k) K040419

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780112471 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040419 Date25 Mar 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040419 decided 25 Mar 2005 Active
  • FDA GUDID UDI-DI 10381780112471 listed 22 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040419
  2. Listed FDA GUDID 10381780112471

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trel-X Putty
Generic name
Human-derived demineralized bone matrix implant
Model / Ref / Catalog
TXP05
Primary DI / UDI-DI
10381780112471
510(k) Number
FDA product code
MQV
GMDN term
Human-derived demineralized bone matrix implant
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MQV (FILLER, BONE VOID, CALCIUM COMPOUND).

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • HCT/P
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)