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510(k) K890185

C-S IMPACTOR by Orthopedic Systems, Inc. — Product Code LYP

K890185 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "C-S IMPACTOR". The FDA issued a decision of Substantially Equivalent on April 6, 1989. The device falls under product code LYP (Accessories, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1989
Date Received
January 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Orthopedic Systems, Inc.

  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • 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)

FDA data resources