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510(k) K830255

OSTEOTOMY BONE STAPLE by Techmedica, Inc. — Product Code HXJ

K830255 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "OSTEOTOMY BONE STAPLE". 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. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
January 25, 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 Techmedica, Inc.

  • K933935 — CKS POROUS COATED FEMORAL COMPONENT (October 11, 1994)
  • K932017 — TECHMEDICA CONTINUUM HIP WITH HA COATING (September 1, 1994)
  • K931929 — TECHMEDICA CONTINUUM HIP SYSTEM (March 29, 1994)
  • K926387 — TECHMEDICA STANDARD CEMENTED HIP SYSTEM (February 1, 1994)
  • K925420 — TECHMEDICA STANDARD BIPOLAR SYSTEM (September 28, 1993)
  • K923808 — MULLER STRAIGHT STEM FEMORAL PROSTHESIS (July 27, 1993)
  • K926579 — TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE (April 6, 1993)
  • K911058 — TECHMEDICA CAD/CAM CUSTOM HIP (February 23, 1993)
  • K925181 — TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP (February 5, 1993)
  • K920080 — CONTINUUM KNEE SYSTEM (September 1, 1992)

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)
  • K830456 — STAPLE INSERTER-EXTRACTOR FOR ARTHROS (March 9, 1983)

FDA data resources