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510(k) K915529

FPC/SFPC/RFPC ACETABULAR COMPONENT by Implantology Corp. — Product Code JDL

K915529 is an FDA 510(k) premarket notification submitted by Implantology Corp. for the device "FPC/SFPC/RFPC ACETABULAR COMPONENT". The FDA issued a decision of Substantially Equivalent on July 13, 1993. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Implantology Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1993
Date Received
December 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type

Other clearances by Implantology Corp.

  • K934729 — UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED (July 22, 1994)
  • K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT (June 29, 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 JDL

  • K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (August 7, 2008)
  • K070785 — DYNASTY ACETABULAR SYSTEM (July 11, 2007)
  • K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (December 6, 2006)
  • K051995 — PROFEMUR RENAISSANCE HIP STEM (August 22, 2005)
  • K051348 — CONSERVE TOTAL FEMORAL HEAD (August 19, 2005)
  • K042841 — M2A/C2A ACETABULAR SYSTEM (December 21, 2004)
  • K041586 — PROFEMUR S HIP STEM (July 9, 2004)
  • K041114 — PROFEMUR TAPERED HIP STEM (May 28, 2004)
  • K004043 — METAL TRANSCEND ARTICULATION SYSTEM (July 13, 2001)
  • K950542 — METAL BACKED ACETABULAR COMPONENT (May 25, 1995)

FDA data resources