Home / 510(k) Clearances / K946165

510(k) K946165

CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM by Elekta Instruments, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1995
Date Received
December 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Elekta Instruments, Inc.

  • K983678 — ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE (January 15, 1999)
  • K955064 — SPETZLER TI 100 ANEURYSM CLIP (October 17, 1996)
  • K941823 — LEKSELL NEURO GENERATOR AND ACCESSORIES (March 22, 1996)
  • K943468 — LEKSELL SURGIPLAN (January 20, 1995)
  • K932261 — ES-100 ACCESSORIES (January 7, 1994)
  • K925360 — ES-100 POWER SYSTEM, ES-100 SERIES (September 7, 1993)
  • K914808 — LEKSELL GAMMAPLAN (LGP) (January 23, 1992)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)