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510(k) K830456

STAPLE INSERTER-EXTRACTOR FOR ARTHROS by Instrument Makar, Inc. — Product Code HXJ

K830456 is an FDA 510(k) premarket notification submitted by Instrument Makar, Inc. for the device "STAPLE INSERTER-EXTRACTOR FOR ARTHROS". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code HXJ (Staple Driver), a Class I device regulated under 21 CFR 888.4540. Instrument Makar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
February 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Instrument Makar, Inc.

  • K002600 — LITWIN CRUICATE ANCHOR (November 15, 2000)
  • K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT (November 6, 1998)
  • K963396 — BIOSPHERE SUTURE ANCHOR (May 6, 1997)
  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K960555 — BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR (July 9, 1996)
  • K943249 — BIOABSORBABLE INTERFERENCE SCREW (July 31, 1995)
  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K942828 — MAKAR FULL AND HALF FACE SHIELD (February 23, 1995)
  • K930980 — INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW (February 10, 1994)

Other clearances for product code HXJ

  • K964953 — IN-TAC BONE ANCHOR SYSTEM (February 13, 1997)
  • K962372 — UROTAC BONE ANCHOR INSERTER (August 19, 1996)
  • K930205 — ELECTRIC WIRE DRIVER, MODEL 2640E (August 2, 1993)
  • K834515 — FIXATION STAPLE KIT - DLIDE HAMMER (April 23, 1984)
  • K830255 — OSTEOTOMY BONE STAPLE (March 9, 1983)

FDA data resources