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510(k) K901521

OSTEOTOMES OF VARIOUS TYPES by Mumtaz I. Malik — Product Code LXH

K901521 is an FDA 510(k) premarket notification submitted by Mumtaz I. Malik for the device "OSTEOTOMES OF VARIOUS TYPES". The FDA issued a decision of Substantially Equivalent on September 28, 1990. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Mumtaz I. Malik has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1990
Date Received
April 2, 1990
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 Mumtaz I. Malik

  • K901511 — CHISEL, BONE, SURGICAL (September 28, 1990)
  • K901289 — RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS (September 28, 1990)
  • K901420 — VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 (September 28, 1990)
  • K893902 — 4 X 4 STERILE GAUZE SPONGE TRAY (July 14, 1989)
  • K890071 — STERILE LACERATION TRAY (January 24, 1989)
  • K884195 — GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) (October 24, 1988)

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