Home / 510(k) Clearances / K010545

510(k) K010545

TBW by Tri-Med, Inc. — Product Code NDL

K010545 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "TBW". The FDA issued a decision of Substantially Equivalent on June 6, 2001. The device falls under product code NDL (Pin, Fixation, Smooth, Metallic), a Class II device regulated under 21 CFR 888.3040. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
February 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth, Metallic
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Tri-Med, Inc.

  • K040112 — TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE (March 12, 2004)
  • K030877 — TRIMED RADIAL BULLET (February 5, 2004)
  • 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)

Other clearances for product code NDL

  • K010847 — K'FIX (June 19, 2001)

FDA data resources