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510(k) K892059

FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR by Protek, Inc. — Product Code LZY

K892059 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR". The FDA issued a decision of Substantially Equivalent on July 19, 1989. The device falls under product code LZY (Prosthesis, Hip, Hemi-, Femoral, Metal Ball), a Class II device regulated under 21 CFR 888.3360. Protek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1989
Date Received
March 29, 1989
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 Protek, Inc.

  • K893785 — ARC-2F ACETABULAR CUP (August 9, 1989)
  • K893959 — P.S.A. FEMORAL HIP PROSTHESIS (July 25, 1989)
  • K883794 — RESUBMITTED CLW ACETABULAR CUP W/SULMESH (May 26, 1989)
  • K884952 — VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC (May 10, 1989)
  • K884889 — MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. (February 27, 1989)
  • K890054 — M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. (February 8, 1989)
  • K884789 — NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI (February 8, 1989)
  • K884888 — MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS (December 29, 1988)
  • K882671 — SAMUELSON SCREWLOC CUP (October 20, 1988)
  • K874093 — SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP (January 27, 1988)

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)
  • K915548 — IONGUARD TITANIUM MODULAR HEADS (March 10, 1992)
  • K903084 — MODULAR CATHCART FRACTURE SYSTEM (October 3, 1990)
  • K896580 — UNI-POLAR HEAD (February 15, 1990)

FDA data resources