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510(k) K921801

MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM by Techmedica, Inc. — Product Code JEY

K921801 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM". The FDA issued a decision of Substantially Equivalent on July 15, 1992. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1992
Date Received
April 13, 1992
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 Techmedica, Inc.

  • K933935 — CKS POROUS COATED FEMORAL COMPONENT (October 11, 1994)
  • K932017 — TECHMEDICA CONTINUUM HIP WITH HA COATING (September 1, 1994)
  • K931929 — TECHMEDICA CONTINUUM HIP SYSTEM (March 29, 1994)
  • K926387 — TECHMEDICA STANDARD CEMENTED HIP SYSTEM (February 1, 1994)
  • K925420 — TECHMEDICA STANDARD BIPOLAR SYSTEM (September 28, 1993)
  • K923808 — MULLER STRAIGHT STEM FEMORAL PROSTHESIS (July 27, 1993)
  • K926579 — TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE (April 6, 1993)
  • K911058 — TECHMEDICA CAD/CAM CUSTOM HIP (February 23, 1993)
  • K925181 — TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP (February 5, 1993)
  • K920080 — CONTINUUM KNEE SYSTEM (September 1, 1992)

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