{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-26", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "proprietary_name": [ "T30 Reduction Screw Power Driver 5.5mm (OIN-01104)", "Double Head Connector Caddy (GIN-00001)", "Cannulated Ratchet I-Handle (OIN-00040)", "Poly Screw Driver Reduction (OIN-00014)", "AWL (OIN-00001)", "T30 MIS Screw Driver 5.5mm (MIN-00005)", "Cannulated Quick Screw Driver (MIN-00006)", "K-Wire, D1.5mm x L480mm Uni-Thread TIP 1.5 * 480 mm (MIN-00104-480)", "Mono Screw Driver (OIN-00015)", "Open Set Screw Starter 5.5mm centerline (OIN-00030SS)", "Quick Screw Driver (OIN-00017)", "Open Set Screw Starter 5.5mm ball (OIN-00030S)", "Double Lead TAP 7mm (OIN-00011)", "T30 MIS Screw Navigation Driver 5.5mm (MIN-00105)", "T30 Reduction Screw Driver 5.5mm blue (OIN-01000)", "Persuader 5.5mm (OIN-00026)", "Double Lead TAP 4mm (OIN-00008)", "Torque Limit Handle, 13N (OIN-00043)", "Coronal Bender ® (OIN-00123", "T30 Reduction Screw Navigation Driver 5.5mm (OIN-01105)", "CrossLink Fixation Driver (OIN-00033)", "Guide Pin A (OIN-00004)", "Rod Holder (OIN-00019)", "T30 Open Screw Driver 5.5mm blue (OIN-00005A)", "K-Wire, D1.5mm x L480mm Bi-Diamond TIP 1.5 * 480 mm (MIN-00101-480)", "K-Wire, D1.5mm x L480mm ROUND TIP (Nitinol) (MIN-00001)", "MIS Implant Container (MTR-00001)", "DILATOR, ID1.8 x OD10mm (MIN-00007)", "MIS Instrument Container (MTR-00002)", "Rod Bender (OIN-00021)", "Double Lead TAP 6mm (OIN-00010)", "Rod Gripper (OIN-00020)", "DILATOR, ID10 x OD14mm (MIN-00008)", "Pedicle Probe, CR (OIN-00003)", "Pedicle Probe, ST (OIN-00002)", "K-Wire, D1.5mm x L480mm Uni-Diamond TIP 1.5 * 480 mm (MIN-00102-480)", "Coronal Bender (L) (OIN-00122)", "K-Wire, D1.5mm x L480mm Bi-Threaded TIP 1.5 * 480 mm (MIN-00103-480)", "Double Lead TAP 5mm (OIN-00009)", "Table Top Rod Cutter & Rod Bender 5.5mm (OIN-00221)", "Distractor (OIN-00028)", "Ball Tip Tester, CR (OIN-00007)", "LS Anti-Torque Device (MIN-00012)", "Guide Pin B (OIN-00005)", "Double Lead TAP 8mm (OIN-00012)", "MIS TYPE IMPLANTS CONTAINER (MTR-00001, AICN-1005-0003, and others)", "SLEEVE CUTTER (MIN-00013)", "Cannulated 6 Tap (MIN-00003)", "T30 Open Screw Navigation Driver 5.5mm Locking (OIN-00106)", "Cannulated Ratchet T-handle, 1/4\" Square (OIN-00041)", "Double Lead TAP 4.5mm (OIN-00008H)", "Open Screw Instrument Container Type A (OTR-00002)", "T30 Open Screw Navigation Driver 5.5mm (OIN-00105)", "T30 MIS Screw Navigation Driver 5.5mm Locking (MIN-00106)", "Compressor (OIN-00027)", "Head Alignment (OIN-00018)", "Caliper 30-120mm (MIN-00011)", "Ball Tip Tester, ST (OIN-00006)", "CrossLink Driver (OIN-00034)", "Open Screw Implant Container (OTR-00001)", "In-situ Bender ® (OIN-00023)", "T30 Open Screw Driver 5.5mm (OIN-00013)", "In-situ Bender (L) (OIN-00022)", "Cannulated 7 Tap (MIN-00004)", "Open Screw Instrument Container Type B (OTR-00003)", "Curved MIS Rod Inserter (MIN-00107)", "Rod Fork 5.5 (OIN-00025)", "Reduction Sleeve Breaker (OIN-00032)", "Mono Screw Driver ( Reduction ) (OIN-00016)", "Table Top Wire Pin And Rod Cutter 70cm 5.5mm (OIN-00222)", "MIS Rod Inserter (MIN-00010)", "Cannulated Ratchet Palm handle, 1/4\" Square (OIN-00042)", "DILATOR, ID14 x OD16mm (MIN-00009)", "K-Wire, D1.5mm x L550mm Bi-ROUND TIP 1.5 * 550 mm (MIN-00001-550)", "T30 MIS Screw Driver 5.5mm blue (MIN-00005A)", "K-Wire, D1.5mm x L500mm Bi-ROUND TIP 1.5 * 500 mm (MIN-00001-500)", "Anti-Torque Device (OIN-00031)", "T30 Reduction Screw Navigation Driver 5.5mm Locking (OIN-01105)", "Ball Tip Tester Double End (OIN-00065)", "Set Screw Starter (OIN-00029)", "Rod Pusher (OIN-00024)", "OPEN TYPE IMPLANTS CONTAINER (OTR-00001, AICN-1005-0004, and others)", "T30 Set Screw Driver T30 (OIN-00030)", "Cannulated 5 Tap (MIN-00002)", "K-Wire, D1.5mm x L480mm Bi-ROUND TIP 1.5 * 480 mm (MIN-00001-480)", "T5 Screw Navigation Driver 3.5mm (OIN-01108)" ], "establishment_type": [ "Manufacture Medical Device", "Develop Specifications But Do Not Manufacture At This Facility", "Complaint File Establishment per 21 CFR 820.198" ], "registration": { "registration_number": "3015426608", "fei_number": "3015426608", "status_code": "1", "initial_importer_flag": "Y", "reg_expiry_date_year": "2026", "name": "Medynus, Inc.", "address_line_1": "18 Technology Dr. Suite 109", "address_line_2": "", "city": "Irvine", "state_code": "CA", "iso_country_code": "US", "zip_code": "92618", "postal_code": "", "us_agent": {}, "owner_operator": { "firm_name": "Medynus, Inc.", "owner_operator_number": "10060045", "official_correspondent": {}, "contact_address": { "address_1": "18 Technology Dr.", "address_2": "Suite 109", "city": "Irvine", "state_code": "CA", "state_province": "", "iso_country_code": "US", "postal_code": "92618" } } }, "pma_number": "", "k_number": "K210420", "products": [ { "product_code": "NKB", "created_date": "2021-07-16", "owner_operator_number": "10060045", "exempt": "", "openfda": { "device_name": "Thoracolumbosacral Pedicle Screw System", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3070", "device_class": "2" } } ] } ] }