D-RAD SMART PACK

Plate, Fixation, Bone

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for D-rad Smart Pack.

Pre-market Notification Details

• Device ID: K132296
• 510k Number: K132296
• Device Name: D-RAD SMART PACK
• Classification: Plate, Fixation, Bone
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Martin Ostmann
• Correspondent: Martin Ostmann; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-23
• Decision Date: 2014-01-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556582985	K132296	000
00885556394649	K132296	000
00885556394441	K132296	000
00885556394397	K132296	000
00885556394342	K132296	000
00885556394298	K132296	000
00885556394243	K132296	000
00885556394199	K132296	000
00885556394144	K132296	000
00885556364598	K132296	000
00885556364543	K132296	000
00885556364499	K132296	000
00885556364444	K132296	000
00885556364390	K132296	000
00885556394748	K132296	000
00885556394847	K132296	000
00885556396445	K132296	000
00885556396346	K132296	000
00885556396247	K132296	000
00885556396148	K132296	000
00885556396049	K132296	000
00885556395943	K132296	000
00885556395844	K132296	000
00885556395745	K132296	000
00885556395349	K132296	000
00885556395240	K132296	000
00885556395141	K132296	000
00885556395042	K132296	000
00885556394946	K132296	000
00885556364345	K132296	000