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510(k) K770204

CEMENT EXTRACTOR DRILL by Depuy, Inc. — Product Code HXY

K770204 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "CEMENT EXTRACTOR DRILL". The FDA issued a decision of Substantially Equivalent on February 8, 1977. The device falls under product code HXY (Brace, Drill), a Class I device regulated under 21 CFR 888.4540. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1977
Date Received
January 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brace, Drill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Depuy, Inc.

  • K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS (March 14, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)

Other clearances for product code HXY

  • K923776 — BENDEREV DRILL GUIDE (November 6, 1992)
  • K892904 — MITEK DRILL GUIDE (September 28, 1989)
  • K880264 — BONE SUTURE FIXATION DEVICE (March 23, 1988)
  • K880381 — TELOS DISTAL TARGETING DEVICE (March 15, 1988)
  • K880046 — HASTING FINGER FIXATOR INSTRUMENTS (February 16, 1988)
  • K831043 — ANDREWS REMOTE CHUCK DRILL (April 28, 1983)

FDA data resources