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510(k) K871870

HSC UNIT ROD by Research Development Corp. — Product Code KWP

K871870 is an FDA 510(k) premarket notification submitted by Research Development Corp. for the device "HSC UNIT ROD". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Research Development Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1987
Date Received
May 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Research Development Corp.

  • K791730 — RING-ORIFICE, TURBULENT FLOW PNEUMOT (November 16, 1979)
  • K771407 — LUNG VOLUME & PRESSURE MONITOR (August 4, 1977)
  • K771019 — LUNG-MECHANICS MONITOR (June 14, 1977)
  • K770785 — MONITOR, RESPIRATORY, TWO-GAS, RDC (May 20, 1977)
  • K770061 — VO RESPIRATORY PNEUMOTACHOGRAPH (January 14, 1977)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources