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510(k) K952495

ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM by Orthopedic Systems, Inc. — Product Code LXH

K952495 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 22, 1996. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1996
Date Received
May 30, 1995
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 Orthopedic Systems, Inc.

  • K920256 — SPINE MOTION ANALYZER WITH EMG (August 10, 1992)
  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K903938 — C FIT CUP (January 4, 1991)
  • K892503 — NUFFIELD TOTAL KNEE (May 4, 1990)
  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)
  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
  • K895218 — CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM (September 12, 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)
  • 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)
  • K933772 — PUNCH SURGICAL (February 1, 1994)

FDA data resources