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Trigen Adolescent Tan

by Smith & Nephew, Inc.

510(k) K040929

Trigen Adolescent Tan is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K040929 on 25 May 2004, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040929 Date25 May 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HSB
Device class
Class II
Regulation
21 CFR Part 888.3020
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Devices cleared under K040929

24 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K040929
UDI-DISize and differences
TRIGEN 71645124
Smith & Nephew, Inc.
71645124 / 7164512400885556037263 —On the market
TRIGEN 71645126
Smith & Nephew, Inc.
71645126 / 7164512603596010541284 —On the market
TRIGEN 71645128
Smith & Nephew, Inc.
71645128 / 7164512803596010541291 —On the market
TRIGEN 71645130
Smith & Nephew, Inc.
71645130 / 7164513003596010541307 —On the market
TRIGEN 71645132
Smith & Nephew, Inc.
71645132 / 7164513203596010541314 —On the market
TRIGEN 71645134
Smith & Nephew, Inc.
71645134 / 7164513403596010541321 —On the market
TRIGEN 71645136
Smith & Nephew, Inc.
71645136 / 7164513603596010541338 —On the market
TRIGEN 71645138
Smith & Nephew, Inc.
71645138 / 7164513803596010541345 —On the market
TRIGEN 71645140
Smith & Nephew, Inc.
71645140 / 7164514003596010541352 —On the market
TRIGEN 71646124
Smith & Nephew, Inc.
71646124 / 7164612400885556036006 —On the market
TRIGEN 71646126
Smith & Nephew, Inc.
71646126 / 7164612603596010541369 —On the market
TRIGEN 71646128
Smith & Nephew, Inc.
71646128 / 7164612803596010541376 —On the market
TRIGEN 71646130
Smith & Nephew, Inc.
71646130 / 7164613003596010541383 —On the market
TRIGEN 71646132
Smith & Nephew, Inc.
71646132 / 7164613203596010541390 —On the market
TRIGEN 71646134
Smith & Nephew, Inc.
71646134 / 7164613403596010541406 —On the market
TRIGEN 71646136
Smith & Nephew, Inc.
71646136 / 7164613603596010541413 —On the market
TRIGEN 71646138
Smith & Nephew, Inc.
71646138 / 7164613803596010541420 —On the market
TRIGEN 71646140
Smith & Nephew, Inc.
71646140 / 7164614003596010541437 —On the market
Trigen XT001003-1
Smith & Nephew, Inc.
XT001003-1 / XT001003-100885556590508 —On the market
TRIGEN XT001051-1
Smith & Nephew, Inc.
XT001051-1 / XT001051-100885556662243 —On the market
Trigen XT001162-1
Smith & Nephew, Inc.
XT001162-1 / XT001162-100885556815274 —On the market
Trigen XT001162-2
Smith & Nephew, Inc.
XT001162-2 / XT001162-200885556815281 —On the market
Trigen XT001162-3
Smith & Nephew, Inc.
XT001162-3 / XT001162-300885556815304 —On the market
Trigen XT001162-4
Smith & Nephew, Inc.
XT001162-4 / XT001162-400885556815311 —On the market

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →