T2 NAILING SYSTEM

Rod, Fixation, Intramedullary And Accessories

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for T2 Nailing System.

Pre-market Notification Details

• Device ID: K032523
• 510k Number: K032523
• Device Name: T2 NAILING SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Vivian Kelly
• Correspondent: Vivian Kelly; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-15
• Decision Date: 2003-10-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04546540201225	K032523	000
04546540201386	K032523	000
04546540201393	K032523	000
04546540201409	K032523	000
04546540201416	K032523	000
04546540201423	K032523	000
04546540201430	K032523	000
04546540201447	K032523	000
04546540201454	K032523	000
04546540201461	K032523	000
04546540201478	K032523	000
04546540201485	K032523	000
04546540201492	K032523	000
04546540201508	K032523	000
04546540201379	K032523	000
04546540201362	K032523	000
04546540201232	K032523	000
04546540201249	K032523	000
04546540201256	K032523	000
04546540201263	K032523	000
04546540201270	K032523	000
04546540201287	K032523	000
04546540201294	K032523	000
04546540201300	K032523	000
04546540201317	K032523	000
04546540201324	K032523	000
04546540201331	K032523	000
04546540201348	K032523	000
04546540201355	K032523	000
04546540201515	K032523	000
04546540201522	K032523	000
04546540201683	K032523	000
04546540201690	K032523	000
04546540201706	K032523	000
04546540201713	K032523	000
04546540201720	K032523	000
04546540379740	K032523	000
04546540379757	K032523	000
04546540379764	K032523	000
04546540379771	K032523	000
04546540379788	K032523	000
04546540673237	K032523	000
04546540673251	K032523	000
04546540673268	K032523	000
04546540201676	K032523	000
04546540201669	K032523	000
04546540201539	K032523	000
04546540201546	K032523	000
04546540201553	K032523	000
04546540201560	K032523	000
04546540201577	K032523	000
04546540201584	K032523	000
04546540201591	K032523	000
04546540201607	K032523	000
04546540201614	K032523	000
04546540201621	K032523	000
04546540201638	K032523	000
04546540201645	K032523	000
04546540201652	K032523	000
07613153295563	K032523	000