AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws

Plate, Fixation, Bone

Industrias Medicas Sampedro S.A.S

The following data is part of a premarket notification filed by Industrias Medicas Sampedro S.a.s with the FDA for Affinity – Variable Angle Distal Radius System, Affinity – Variable Angle Distal Radius Plates, Affinity – Variable Angle Distal Radius Screws.

Pre-market Notification Details

• Device ID: K191641
• 510k Number: K191641
• Device Name: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws
• Classification: Plate, Fixation, Bone
• Applicant: Industrias Medicas Sampedro S.A.S Carrera 47 No. 100 Sur 40 La Estrella, CO 055468
• Contact: Liliana Zuluaga-idarraga
• Correspondent: Liliana Zuluaga-idarraga; Industrias Medicas Sampedro S.A.S Carrera 47 No. 100 Sur 40 La Estrella, CO 055468
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-19
• Decision Date: 2019-09-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07708434060005	K191641	000
07708434060296	K191641	000
07708434060302	K191641	000
07708434060319	K191641	000
07708434060333	K191641	000
07708434060340	K191641	000
07708434060357	K191641	000
07708434060364	K191641	000
07708434060371	K191641	000
07708434060395	K191641	000
07708434060401	K191641	000
07708434060449	K191641	000
07708434060456	K191641	000
07708434060470	K191641	000
07708434060487	K191641	000
07708434060289	K191641	000
07708434060241	K191641	000
07708434060012	K191641	000
07708434060029	K191641	000
07708434060036	K191641	000
07708434060043	K191641	000
07708434060050	K191641	000
07708434060081	K191641	000
07708434060098	K191641	000
07708434060111	K191641	000
07708434060135	K191641	000
07708434060159	K191641	000
07708434060166	K191641	000
07708434060197	K191641	000
07708434060203	K191641	000
07708434060227	K191641	000
07708434060500	K191641	000
07708434060517	K191641	000
07708434060524	K191641	000
07708434060784	K191641	000
07708434060807	K191641	000
07708434060845	K191641	000
07708434060852	K191641	000
07708434060869	K191641	000
07708434060876	K191641	000
07708434060890	K191641	000
07708434060913	K191641	000
07708434060920	K191641	000
07708434060937	K191641	000
07708434060951	K191641	000
07708434060968	K191641	000
07708434060975	K191641	000
07708434060982	K191641	000
07708434060760	K191641	000
07708434060746	K191641	000
07708434060531	K191641	000
07708434060548	K191641	000
07708434060562	K191641	000
07708434060593	K191641	000
07708434060616	K191641	000
07708434060623	K191641	000
07708434060630	K191641	000
07708434060654	K191641	000
07708434060661	K191641	000
07708434060678	K191641	000
07708434060685	K191641	000
07708434060692	K191641	000
07708434060708	K191641	000
07708434060715	K191641	000
07708434060999	K191641	000