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510(k) K882520

SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS by Karlin Technology, Inc. — Product Code LWG

K882520 is an FDA 510(k) premarket notification submitted by Karlin Technology, Inc. for the device "SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code LWG (Surgical Table Cushion), a Class I device regulated under 21 CFR 878.4950. Karlin Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
June 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Table Cushion
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
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)
  • K893201 — BONE PLATE (April 4, 1990)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K882519 — X-RAY MARKER (August 9, 1988)
  • K882073 — SPINAL NEEDLE (July 18, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K882069 — SPINAL DISTRACTORS, SPANNERS (June 17, 1988)
  • K882077 — MICRODISCECTOMY CURRETTES (June 17, 1988)
  • K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTES (June 17, 1988)

Other clearances for product code LWG

  • K883295 — CHOP SPINE FRAME (August 23, 1988)
  • K874494 — KAMBIN LAMINECTOMY FRAME (November 23, 1987)
  • K873690 — CEDAR(TM) PELVIC CUSHION (October 26, 1987)

FDA data resources