UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE

Prosthesis, Hip, Hemi-, Femoral, Metal

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Unitrax C-taper Neck Adjustment Sleeve.

Pre-market Notification Details

• Device ID: K992570
• 510k Number: K992570
• Device Name: UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Karen Ariemma
• Correspondent: Karen Ariemma; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: KWL
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-02
• Decision Date: 1999-09-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327013481	K992570	000
07613327013474	K992570	000
07613327013467	K992570	000
07613327013450	K992570	000