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510(k) K915548

IONGUARD TITANIUM MODULAR HEADS by Biomet, Inc. — Product Code LZY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1992
Date Received
December 11, 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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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)
  • K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT (June 29, 1993)
  • 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)