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510(k) K882525

SPINAL MICROKNIFE by Karlin Technology, Inc. — Product Code HTS

K882525 is an FDA 510(k) premarket notification submitted by Karlin Technology, Inc. for the device "SPINAL MICROKNIFE". The FDA issued a decision of Substantially Equivalent on September 22, 1988. The device falls under product code HTS (Knife, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Karlin Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1988
Date Received
June 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Orthopedic
Device Class
Class I
Regulation Number
888.4540
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)
  • K893201 — BONE PLATE (April 4, 1990)
  • 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)
  • K882077 — MICRODISCECTOMY CURRETTES (June 17, 1988)
  • K882069 — SPINAL DISTRACTORS, SPANNERS (June 17, 1988)
  • K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTES (June 17, 1988)

Other clearances for product code HTS

  • K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS) (February 22, 1994)
  • K933921 — ACUFLEX DISPOSABLE KNIVES (January 26, 1994)
  • K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613 (November 2, 1987)
  • K873714 — BANANA KNIFE, DISPOSABLE #TM-1612 (November 2, 1987)
  • K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611 (November 2, 1987)
  • K873712 — STANDARD KNIFE, DISPOSABLE #TM-1610 (October 15, 1987)
  • K842820 — ARTHROSCOPY KNIVES (August 14, 1984)
  • K771851 — ARTHROSCOPE OPERATIVE KNIFE SET (October 27, 1977)

FDA data resources