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510(k) K203282

TECHFIT Patient-Specific Maxillofacial System by Industrias Medicas Sampedro S.A.S — Product Code JEY

K203282 is an FDA 510(k) premarket notification submitted by Industrias Medicas Sampedro S.A.S for the device "TECHFIT Patient-Specific Maxillofacial System". The FDA issued a decision of Substantially Equivalent on May 19, 2021. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Industrias Medicas Sampedro S.A.S has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2021
Date Received
November 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Industrias Medicas Sampedro S.A.S

  • K191641 — AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal (September 16, 2019)

Other clearances for product code JEY

  • K252246 — Leforte MMF System (April 2, 2026)
  • K253373 — Southern Craniomaxillofacial (CMF) System (December 19, 2025)
  • K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsor (November 7, 2025)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K233874 — tmCMF Solution (July 11, 2024)
  • K232889 — METICULY Patient-specific titanium maxillofacial mesh implant (April 30, 2024)
  • K232350 — Stryker Facial iD System (January 13, 2024)
  • K230398 — MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (September 26, 2023)
  • K230733 — Stryker Resorbable Fixation System (August 5, 2023)

FDA data resources