SMART Taylor Spatial Frame

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smart Taylor Spatial Frame.

Pre-market Notification Details

• Device ID: K210953
• 510k Number: K210953
• Device Name: SMART Taylor Spatial Frame
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: Smith & Nephew, Inc. 1450 E Brooks Rd Memphis, TN 38116
• Contact: Thomas Fearnley
• Correspondent: Thomas Fearnley; Smith & Nephew, Inc. 1450 E Brooks Rd Memphis, TN 38116
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-30
• Decision Date: 2021-07-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556745625	K210953	000
00885556745496	K210953	000
00885556745489	K210953	000
00885556745465	K210953	000
00885556745458	K210953	000
00885556745441	K210953	000
00885556745434	K210953	000
00885556745427	K210953	000
00885556745410	K210953	000
00885556745397	K210953	000
00885556745380	K210953	000
00885556745502	K210953	000
00885556745519	K210953	000
00885556745618	K210953	000
00885556745601	K210953	000
00885556745595	K210953	000
00885556745588	K210953	000
00885556745571	K210953	000
00885556745564	K210953	000
00885556745557	K210953	000
00885556745540	K210953	000
00885556745533	K210953	000
00885556745526	K210953	000
00885556745373	K210953	000
00885556745366	K210953	000
00885556745359	K210953	000
00885556871843	K210953	000
00885556871829	K210953	000
00885556871805	K210953	000
00885556871775	K210953	000
00885556871768	K210953	000
00885556871751	K210953	000
00885556871744	K210953	000
00885556871737	K210953	000
00885556871812	K210953	000
00885556871799	K210953	000
00885556871836	K210953	000
00885556746110	K210953	000
00885556745335	K210953	000
00885556745328	K210953	000
00885556745311	K210953	000
00885556745304	K210953	000
00885556745281	K210953	000
00885556745250	K210953	000
00885556808016	K210953	000
00885556746387	K210953	000
00885556746370	K210953	000
00885556746127	K210953	000
00885556871782	K210953	000
00885556799987	K210953	000
00885556799857	K210953	000
00885556799840	K210953	000
00885556799833	K210953	000
00885556799826	K210953	000
00885556799819	K210953	000
00885556799802	K210953	000
00885556799796	K210953	000
00885556799789	K210953	000
00885556799772	K210953	000
00885556799765	K210953	000
00885556799864	K210953	000
00885556799871	K210953	000
00885556799970	K210953	000
00885556799963	K210953	000
00885556799956	K210953	000
00885556799949	K210953	000
00885556799932	K210953	000
00885556799925	K210953	000
00885556799918	K210953	000
00885556799901	K210953	000
00885556799895	K210953	000
00885556799888	K210953	000
00885556799758	K210953	000
00885556799741	K210953	000
00885556799734	K210953	000
20885556746114	K210953	000
20885556746091	K210953	000
20885556746077	K210953	000
00885556746066	K210953	000
00885556746059	K210953	000
00885556746042	K210953	000
20885556746015	K210953	000
20885556746008	K210953	000
20885556745995	K210953	000
00885556745649	K210953	000
20885556746121	K210953	000
00885556746233	K210953	000
00885556799727	K210953	000
00885556799710	K210953	000
00885556799703	K210953	000
00885556799697	K210953	000
00885556799680	K210953	000
00885556799673	K210953	000
00885556799666	K210953	000
00885556799659	K210953	000
00885556799642	K210953	000
00885556799635	K210953	000
00885556745632	K210953	000