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Sampedro 0

by Industrias Medicas Sampedro S.A.S 96 variants

Sampedro 0 (PTPMI16) is an orthopaedic fixation plate (FDA Class II; FDA product code HRS, Plate, 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 11 May 2022 (UDI-DI 07708434060142), 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 Number07708434060142 UDI-DI Date11 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 07708434060142 listed 11 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220199
  2. Listed FDA GUDID 07708434060142

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  • Withdrawn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 fixation plate, non-bioabsorbable, non-sterile
Model / Ref / Catalog
0, PTPMI16
Primary DI / UDI-DI
07708434060142
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, 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 fixation plate, 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)