SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)

Rod, Fixation, Intramedullary And Accessories

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Angular Stable Locking System (asls).

Pre-market Notification Details

• Device ID: K090241
• 510k Number: K090241
• Device Name: SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Contact: Sheri L Musgnung
• Correspondent: Sheri L Musgnung; SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-02
• Decision Date: 2009-06-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H67904025450S0	K090241	000
H67904025424S0	K090241	000
H67904025422S0	K090241	000
H67904025420S0	K090241	000
H67904025418S0	K090241	000
H67904025416S0	K090241	000
H67904025590S0	K090241	000
H67904025585S0	K090241	000
H67904025580S0	K090241	000
H67904025575S0	K090241	000
H67904025426S0	K090241	000
H67904025428S0	K090241	000
H67904025430S0	K090241	000
H67904025448S0	K090241	000
H67904025446S0	K090241	000
H67904025444S0	K090241	000
H67904025442S0	K090241	000
H67904025440S0	K090241	000
H67904025438S0	K090241	000
H67904025436S0	K090241	000
H67904025434S0	K090241	000
H67904025432S0	K090241	000
H67904025570S0	K090241	000
H67904025568S0	K090241	000
H67904025566S0	K090241	000
H67904025538S0	K090241	000
H67904025536S0	K090241	000
H67904025534S0	K090241	000
H67904025532S0	K090241	000
H67904025530S0	K090241	000
H67904025528S0	K090241	000
H67904025526S0	K090241	000
H67904025524S0	K090241	000
H67904025522S0	K090241	000
H67904025540S0	K090241	000
H67904025542S0	K090241	000
H67904025544S0	K090241	000
H67904025564S0	K090241	000
H67904025562S0	K090241	000
H67904025560S0	K090241	000
H67904025558S0	K090241	000
H67904025556S0	K090241	000
H67904025554S0	K090241	000
H67904025550S0	K090241	000
H67904025548S0	K090241	000
H67904025546S0	K090241	000
H67904025520S0	K090241	000
H67904025452S0	K090241	000
H67908025057S0	K090241	000
H67904025668S0	K090241	000
H67904025666S0	K090241	000
H67904025664S0	K090241	000
H67904025662S0	K090241	000
H67904025660S0	K090241	000
H67904025658S0	K090241	000
H67904025656S0	K090241	000
H67904025654S0	K090241	000
H67904025652S0	K090241	000
H67904025670S0	K090241	000
H67904025675S0	K090241	000
H67904025680S0	K090241	000
H67908025044S0	K090241	000
H67908025032S0	K090241	000
H67904025715S0	K090241	000
H67904025710S0	K090241	000
H67904025705S0	K090241	000
H67904025700S0	K090241	000
H67904025695S0	K090241	000
H67904025690S0	K090241	000
H67904025685S0	K090241	000
H67904025650S0	K090241	000
H67904025648S0	K090241	000
H67904025646S0	K090241	000
H67904025552S0	K090241	000
H67904025470S0	K090241	000
H67904025468S0	K090241	000
H67904025466S0	K090241	000
H67904025464S0	K090241	000
H67904025462S0	K090241	000
H67904025460S0	K090241	000
H67904025458S0	K090241	000
H67904025456S0	K090241	000
H67904025622S0	K090241	000
H67904025624S0	K090241	000
H67904025626S0	K090241	000
H67904025644S0	K090241	000
H67904025642S0	K090241	000
H67904025640S0	K090241	000
H67904025638S0	K090241	000
H67904025636S0	K090241	000
H67904025634S0	K090241	000
H67904025632S0	K090241	000
H67904025630S0	K090241	000
H67904025628S0	K090241	000
H67904025454S0	K090241	000