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510(k) K902819

LAMINECTOMY ROGEUR by Ruggles Corp. — Product Code LXH

K902819 is an FDA 510(k) premarket notification submitted by Ruggles Corp. for the device "LAMINECTOMY ROGEUR". The FDA issued a decision of Substantially Equivalent on August 9, 1990. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Ruggles Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
June 27, 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 Ruggles Corp.

  • K903485 — TITANIUM MESH (February 21, 1991)
  • K902818 — MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT (September 20, 1990)
  • K902850 — ZEPPELIN INSTRUMENTS (July 18, 1990)
  • K893415 — TRANS-ORAL DEPTH GAUGE (June 7, 1989)

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