SKELETAL DYNAMICS STERILIZATION TRAYS

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

SKELETAL DYNAMICS, LLC

The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Skeletal Dynamics Sterilization Trays.

Pre-market Notification Details

• Device ID: K102103
• 510k Number: K102103
• Device Name: SKELETAL DYNAMICS STERILIZATION TRAYS
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176
• Contact: Ana M Escagedo
• Correspondent: Ana M Escagedo; SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami, FL 33176
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-27
• Decision Date: 2010-12-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841506138176	K102103	000
00841506140971	K102103	000
00841506140988	K102103	000
00841506140995	K102103	000
00841506141008	K102103	000
00841506141190	K102103	000
00841506145518	K102103	000
00841506145525	K102103	000
00841506131986	K102103	000
00841506131689	K102103	000
00841506131870	K102103	000
00841506131887	K102103	000
00841506131894	K102103	000
00841506131900	K102103	000
00841506140964	K102103	000
00841506140957	K102103	000
00841506138183	K102103	000
00841506138190	K102103	000
00841506138206	K102103	000
00841506138213	K102103	000
00841506138220	K102103	000
00841506138237	K102103	000
00841506140889	K102103	000
00841506140896	K102103	000
00841506140902	K102103	000
00841506140919	K102103	000
00841506140926	K102103	000
00841506140933	K102103	000
00841506140940	K102103	000
00841506131917	K102103	000
00841506100371	K102103	000
00841506100531	K102103	000
00841506100548	K102103	000
00841506100555	K102103	000
00841506100562	K102103	000
00841506100579	K102103	000
00841506100586	K102103	000
00841506100630	K102103	000
00841506100647	K102103	000
00841506100654	K102103	000
00841506100661	K102103	000
00841506100678	K102103	000
00841506100685	K102103	000
00841506100692	K102103	000
00841506100524	K102103	000
00841506100517	K102103	000
00841506100388	K102103	000
00841506100395	K102103	000
00841506100401	K102103	000
00841506100418	K102103	000
00841506100425	K102103	000
00841506100432	K102103	000
00841506100449	K102103	000
00841506100456	K102103	000
00841506100463	K102103	000
00841506100470	K102103	000
00841506100487	K102103	000
00841506100494	K102103	000
00841506100500	K102103	000
00841506109176	K102103	000