The following data is part of a premarket notification filed by Meril Healthcare Pvt. Ltd. with the FDA for Armar / Artis Small Fragment And Calcaneal Plates & Mboss / Fixion Screws, Armar/ Artis Humerus And Olecranon Plates & Mboss/fixion Screws, Armar / Artis Tibia And Buttress Plates & Mboss/fixion Screws, Armar / Artis 2.4mm Plates & Mboss/fixion Screw.
| Device ID | K171320 |
| 510k Number | K171320 |
| Device Name: | ARMAR / ARTIS Small Fragment And Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus And Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia And Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screw |
| Classification | Plate, Fixation, Bone |
| Applicant | Meril Healthcare Pvt. Ltd. First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi, IN 396191 |
| Contact | Umesh Sharma |
| Correspondent | Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-04 |
| Decision Date | 2018-03-08 |
| Summary: | summary |