Sampedro 0
by Industrias Medicas Sampedro S.A.S 96 variants
Sampedro 0 (PTPLI18) 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 07708434060258), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07708434060258 | Date11 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220199 | Date21 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 07708434060258
- FDA 510(k) database K220199
Across registries
- FDA 510(k) K220199 decided 21 Mar 2022 Active
- FDA GUDID UDI-DI 07708434060258 listed 11 May 2022 Listed
Timeline
- Cleared FDA 510(k) K220199
- Listed FDA GUDID 07708434060258
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sampedro
- Generic name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile
- Model / Ref / Catalog
- 0, PTPLI18
- Primary DI / UDI-DI
- 07708434060258
- 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
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