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510(k) K834108

NEEDLE BENDER TX8225 by Today'S Machining & Design, Inc. — Product Code LXH

K834108 is an FDA 510(k) premarket notification submitted by Today'S Machining & Design, Inc. for the device "NEEDLE BENDER TX8225". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Today'S Machining & Design, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
November 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Today'S Machining & Design, Inc.

  • K853604 — ACE-KYLE DYE INJECTION NEEDLE P/N 14082 (November 12, 1985)
  • K823676 — DISC NEEDLE SET #TX-8220 (January 9, 1983)
  • K823675 — FRONING GUIDANCE SYSTEM #TX-8200 (January 5, 1983)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)

FDA data resources