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510(k) K915528

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

K915528 is an FDA 510(k) premarket notification submitted by Implantology Corp. for the device "BHR BIPOLAR FEMORAL HEAD COMPONENT". The FDA issued a decision of Substantially Equivalent on June 29, 1993. The device falls under product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), a Class II device regulated under 21 CFR 888.3360. Implantology Corp. has at least 8 other 510(k) clearances on record.

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

Other clearances by Implantology Corp.

  • K934729 — UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED (July 22, 1994)
  • K915529 — FPC/SFPC/RFPC ACETABULAR COMPONENT (July 13, 1993)
  • K915527 — CPS ACETABULAR COMPONENT (June 24, 1993)
  • K915385 — PPC HIP STEM COMPONENT (May 17, 1993)
  • K924099 — UFC HIP STEM COMPONENT (April 30, 1993)
  • K915391 — FPC 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)

FDA data resources