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510(k) K771072

INSERTEO, META.-PHAL.&THUMB CARPO-META by Depuy, Inc. — Product Code HXO

K771072 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "INSERTEO, META.-PHAL.&THUMB CARPO-META". The FDA issued a decision of Substantially Equivalent on June 27, 1977. The device falls under product code HXO (Pusher, Socket), 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
June 27, 1977
Date Received
June 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pusher, Socket
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 HXO

  • K885305 — ACETABULAR CUP PUSHER/IMPACTOR (February 8, 1989)
  • K803165 — ACETABULAR CEMENT COMPRESSOR (December 31, 1980)

FDA data resources