NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

ZIMMER TRABECULAR METAL TECHNOLOGY

The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Nexgen Lcck Trabecular Metal (tm) Coupled Tibial Cones Provisionals To Nexgen Lcck Trabecular Metal (tm) Coupled Tibial.

Pre-market Notification Details

• Device ID: K120990
• 510k Number: K120990
• Device Name: NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
• Applicant: ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054
• Contact: Judith Rosen
• Correspondent: Judith Rosen; ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054
• Product Code: MBH
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-02
• Decision Date: 2012-06-29
• Summary: summary

NIH GUDID Devices

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