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510(k) K934260

BARRIER BONE WAX APPLICATOR by Phillips Pharmaceuticals, Inc. — Product Code LXH

K934260 is an FDA 510(k) premarket notification submitted by Phillips Pharmaceuticals, Inc. for the device "BARRIER BONE WAX APPLICATOR". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
August 31, 1993
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

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  • 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