INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP

Nail, Fixation, Bone

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Intramedullary Nail System, Locking Screw, Nail Cap.

Pre-market Notification Details

• Device ID: K983942
• 510k Number: K983942
• Device Name: INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
• Classification: Nail, Fixation, Bone
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JDS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-05
• Decision Date: 1998-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010409409	K983942	000
03596010104922	K983942	000
03596010104939	K983942	000
03596010104946	K983942	000
03596010104953	K983942	000
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03596010104991	K983942	000
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03596010105059	K983942	000
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03596010105301	K983942	000
00885556048979	K983942	000