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510(k) K893201

BONE PLATE by Karlin Technology, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
April 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Karlin Technology, Inc.

  • K903969 — SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET (September 5, 1990)
  • K893203 — BONE SCREW (April 4, 1990)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K882519 — X-RAY MARKER (August 9, 1988)
  • K882073 — SPINAL NEEDLE (July 18, 1988)
  • K882520 — SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS (July 18, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTES (June 17, 1988)
  • K882077 — MICRODISCECTOMY CURRETTES (June 17, 1988)
  • K882069 — SPINAL DISTRACTORS, SPANNERS (June 17, 1988)

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