QUANTUM M COMPOSITE NAILING SYSTEM

Rod, Fixation, Intramedullary And Accessories

N.M.B. MEDICAL APPLICATIONS, LTD.

The following data is part of a premarket notification filed by N.m.b. Medical Applications, Ltd. with the FDA for Quantum M Composite Nailing System.

Pre-market Notification Details

• Device ID: K091425
• 510k Number: K091425
• Device Name: QUANTUM M COMPOSITE NAILING SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: N.M.B. MEDICAL APPLICATIONS, LTD. 555 THIRTEENTH ST. NW Washington, DC 20004
• Contact: Jonathan S Kahan
• Correspondent: Jonathan S Kahan; N.M.B. MEDICAL APPLICATIONS, LTD. 555 THIRTEENTH ST. NW Washington, DC 20004
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-13
• Decision Date: 2010-01-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290109337258	K091425	000
07290109332154	K091425	000
07290109332147	K091425	000
07290109332130	K091425	000
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07290109332222	K091425	000
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07290109332000	K091425	000
07290109331980	K091425	000
07290109331973	K091425	000
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07290109339634	K091425	000
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07290109337265	K091425	000