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510(k) K231448

TANDEM Hip System by Smith & Nephew, Inc. — Product Code LZY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2023
Date Received
May 18, 2023
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

  • K111145 — ENDO HEAD (August 16, 2011)
  • K974442 — PRE-POWDERED NITRILE EXAMINATION GLOVES (January 5, 1998)
  • K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT (June 29, 1993)
  • 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)