ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.

The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Zirconia Prozyr Ceramic 12/14 Global Taper (gt) Femoral Heads.

Pre-market Notification Details

• Device ID: K971414
• 510k Number: K971414
• Device Name: ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Joann Kuhne
• Correspondent: Joann Kuhne; SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-16
• Decision Date: 1997-07-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010196323	K971414	000
03596010196316	K971414	000
03596010196309	K971414	000
03596010196255	K971414	000
03596010196248	K971414	000
03596010196187	K971414	000
03596010196170	K971414	000