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510(k) K030877

TRIMED RADIAL BULLET by Tri-Med, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2004
Date Received
March 20, 2003
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 Tri-Med, Inc.

  • K040112 — TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE (March 12, 2004)
  • K010545 — TBW (June 6, 2001)
  • K961863 — PARACENTESIS TRAYS (May 28, 1996)
  • K875224 — HUDSON CRANINAL BURRS (January 28, 1988)
  • K850746 — TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI (April 2, 1985)
  • K850745 — TRI-MED MODEL 112 MOISTURE TRAP (April 2, 1985)
  • K850747 — TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR (April 2, 1985)
  • K843681 — RESPIRATION & HEART RATE MONITOR 530 (December 4, 1984)
  • K843285 — TRI-MED 610 CAPNOSTAT GAS ANALYZER (November 13, 1984)
  • K842399 — 48 HOUR SET CHANGES (October 9, 1984)

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  • 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)
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