Home / 510(k) Clearances / K063506

510(k) K063506

LORENZ STERNAL CLOSURE SYSTEM by Walter Lorenz Surgical, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2006
Date Received
November 20, 2006
Clearance Type
Special
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 Walter Lorenz Surgical, Inc.

  • K063386 — LORENZ ORTHODONTIC ANCHORAGE SYSTEM (February 9, 2007)
  • K063052 — LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES (January 12, 2007)
  • K062842 — TWIST DRILL (December 4, 2006)
  • K061384 — LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITAN (June 6, 2006)
  • K042516 — OTOMIMIX (November 8, 2004)
  • K030425 — LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER (May 14, 2004)
  • K040990 — MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS (May 13, 2004)
  • K040983 — LORENZ SELF-DRILLING IMF SCREW (May 5, 2004)
  • K033740 — LORENZ STERNAL CLOSURE SYSTEM (December 15, 2003)
  • K032228 — LORENZ 2.4 SELF DRILLING SCREWS (August 11, 2003)

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)