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510(k) K870083

FERRAY EXTRACTOR by Terray Manufacturing, Inc. — Product Code HWB

K870083 is an FDA 510(k) premarket notification submitted by Terray Manufacturing, Inc. for the device "FERRAY EXTRACTOR". The FDA issued a decision of Substantially Equivalent on February 26, 1987. The device falls under product code HWB (Extractor), a Class I device regulated under 21 CFR 888.4540. Terray Manufacturing, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1987
Date Received
January 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Terray Manufacturing, Inc.

  • K910874 — THORACIC ANTERIOR SPINAL FIXATION PLATE (February 3, 1992)
  • K882934 — CASF CANCELLOUS BONE SCREW, BT650 (October 13, 1988)
  • K882871 — CASF DRILL GUIDE DG 170 (September 23, 1988)
  • K883193 — CASF STERILIZATION TRAY (August 10, 1988)
  • K883125 — CASF STERILIZATION TRAY (August 10, 1988)
  • K870085 — ANTERIOR SPINAL FIXATION PLATE (June 30, 1987)
  • K870082 — BONE PLATE (May 6, 1987)
  • K870084 — RD 140 SURGICAL BENDER (January 28, 1987)

Other clearances for product code HWB

  • K873710 — MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350 (November 2, 1987)
  • K870844 — SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR (March 13, 1987)
  • K801327 — THE EXTRACTOR I TM (June 9, 1980)
  • K780300 — HIP PLATE REMOVAL INSTRUMENT (February 28, 1978)

FDA data resources