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Sampedro 0

by Industrias Medicas Sampedro S.A.S 96 variants

Sampedro 0 (TCIAT3540) is an orthopaedic bone screw (FDA Class II; FDA product code HWC, Screw, Fixation, Bone) made by Industrias Medicas Sampedro S.A.S, cleared under FDA 510(k) K220199 on 21 Mar 2022 and listed in FDA GUDID since 12 May 2022 (UDI-DI 07709899149939), 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) K220199

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 Number07709899149939 UDI-DI Date12 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220199 Date21 Mar 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220199 decided 21 Mar 2022 Active
  • FDA GUDID UDI-DI 07709899149939 listed 12 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220199
  2. Listed FDA GUDID 07709899149939

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sampedro
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
0, TCIAT3540
Primary DI / UDI-DI
07709899149939
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K220199)

and 8 more cleared under K220199

Similar devices in this category

Other devices filed under Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Other devices from Industrias Medicas Sampedro S.A.S

  • Sampedro 0

    Class I

  • Sampedro 1

    Class II

  • Sampedro 0

    Class II

  • Sampedro 0

    Class II

See all devices from Industrias Medicas Sampedro S.A.S →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)