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510(k) K915528

BHR BIPOLAR FEMORAL HEAD COMPONENT by Implantology Corp. — Product Code LZY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1993
Date Received
December 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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  • K915527 — CPS ACETABULAR COMPONENT (June 24, 1993)
  • K915385 — PPC HIP STEM COMPONENT (May 17, 1993)
  • K915391 — FPC HIP STEM COMPONENT (April 30, 1993)
  • K924099 — UFC HIP STEM COMPONENT (April 30, 1993)
  • K915798 — PSK POSTERIOR STABILIZED TOATAL KNEE (March 4, 1993)
  • K915584 — CRK CONDYLAR RESURFACING TOTAL KNEE (February 12, 1993)

Other clearances for product code LZY

  • K231448 — TANDEM Hip System (July 19, 2023)
  • K111145 — ENDO HEAD (August 16, 2011)
  • K974442 — PRE-POWDERED NITRILE EXAMINATION GLOVES (January 5, 1998)
  • K915548 — IONGUARD TITANIUM MODULAR HEADS (March 10, 1992)
  • K903084 — MODULAR CATHCART FRACTURE SYSTEM (October 3, 1990)
  • K896580 — UNI-POLAR HEAD (February 15, 1990)
  • K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (July 19, 1989)