This page includes the latest FDA filings for Amplify Surgical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3015255331 |
| FEI Number | 3015255331 |
| Name | AMPLIFY SURGICAL INC. |
| Owner & Operator | Amplify Surgical Inc. |
| Contact Address | 26020 Acero #100 Mission Viejo CA 92691 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 27071 Cabot Road #118 Laguna Hills, CA 92653 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| AMPLIFY SURGICAL, INC. | DUALXS T/PLIF 12 DEG x 7-10MM | 2025-05-21 |
| AMPLIFY SURGICAL, INC. | DUALX LLIF IMPLANT STERILIZATION CADDY | 2025-05-21 |
| AMPLIFY SURGICAL, INC. | DUALXS T/PLIF LOCKOUT SCREW SHORT | 2025-05-21 |
| AMPLIFY SURGICAL, INC. | DualX LLIF IMPLANT HOLDER 55mm | 2025-05-21 |
| AMPLIFY SURGICAL, INC. | DualX LLIF IMPLANT HOLDER 45mm | 2025-05-21 |
| AMPLIFY SURGICAL, INC. | DualX LLIF IMPLANT HOLDER 40mm | 2025-05-21 |
| AMPLIFY SURGICAL, INC. | dualX Graft Delivery Tip (USA) | 2025-05-21 |
| Amplify Surgical, Inc. | DUALX LLIF LOCKOUT SCREW 2 X 55MM | 2025-05-08 |
| Amplify Surgical, Inc. | DUALX LLIF LOCKOUT SCREW 2 X 50MM | 2025-05-08 |
| Amplify Surgical, Inc. | DUALX LLIF LOCKOUT SCREW 2 X 45MM | 2025-05-08 |
| Amplify Surgical, Inc. | DUALX LLIF LOCKOUT SCREW 2 X 40MM | 2025-05-08 |
| Amplify Surgical, Inc. | DUALX LLIF LOCKOUT SCREW 2 X 40MM | 2025-05-08 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 12 DEG x 45MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 12 DEG x 40MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 7 DEG x 50MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 7 DEG x 45MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 8-11MM x 7 DEG x 55MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 8-11MM x 7 DEG x 50MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 8-11MM x 7 DEG x 40MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 7-9MM x 0 DEG x 55MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 7-9MM x 0 DEG x 50MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 7-9MM x 0 DEG x 45MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 7-9MM x 0 DEG x 40MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 12 DEG x 55MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 12 DEG x 50MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 12 DEG x 45MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX LLIF 10-13MM x 12 DEG x 40MM | 2025-05-05 |
| Amplify Surgical, Inc. | DUALX LLIF 10-13MM x 12 DEG x 45MM | 2025-05-05 |
| Amplify Surgical, Inc. | DUALX LLIF 10-13MM x 12 DEG x 40MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX PLIF 15 DEG x 11-14MM | 2025-05-05 |
| Amplify Surgical, Inc. | KIT DUALX PLIF 15 DEG x 11-13MM | 2025-05-05 |
| Amplify Surgical, Inc. | DUALXS ACME INSERTER HANDLE ACME | 2025-04-30 |
| Amplify Surgical, Inc. | DualXS Inserter Handle Acme | 2024-09-11 |
| Amplify Surgical, Inc. | DualXS Fixed ACME Drawbar | 2024-09-11 |
| Amplify Surgical, Inc. | DualXS Inserter Outer Shaft | 2024-09-11 |
| Amplify Surgical, Inc. | DualXS Implant Retainer Shaft | 2024-09-11 |
| Amplify Surgical, Inc. | DUALX ACME PIN | 2024-09-11 |
| Amplify Surgical, Inc. | DUALXS T/PLIF 15 DEG x 8-11MM | 2024-06-28 |
| Amplify Surgical, Inc. | DUALXS T/PLIF 12 DEG x 7-10MM | 2024-06-28 |
| Amplify Surgical, Inc. | DUALXS T/PLIF 8 DEG x 7-9MM | 2024-06-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL CANNULA 100MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL CANNULA 90MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL CANNULA 80MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORT CANNULA 70MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORT CANNULA 60MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORT CANNULA 50MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORT CANNULA 40MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORT CANNULA 30MM (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORT HEMOSTATIC AGENT DELIVERY TUBE (USA) | 2024-04-03 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL ROOT RETRACTOR | 2024-01-23 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL ROOT RETRACTOR BAYONET | 2024-01-23 |
| Amplify Surgical, Inc. | DUALXS T/PLIF 15 DEG x 9-12MM | 2024-01-23 |
| Amplify Surgical, Inc. | DUALX IMPLANT STERILIZATION CADDY | 2024-01-23 |
| Amplify Surgical, Inc. | DualX LLIF IMPLANT HOLDER 50mm | 2024-01-23 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL FUSION GUIDE RIGHT | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL FUSION GUIDE LEFT | 2023-08-18 |
| Amplify Surgical, Inc. | DualX SLAP HAMMER INNOMED | 2023-08-18 |
| Amplify Surgical, Inc. | DUALXS EXPANDABLE TRIAL TPLIF | 2023-08-18 |
| Amplify Surgical, Inc. | DUALXS IMPLANT STERILIZATION CADDY | 2023-08-18 |
| Amplify Surgical, Inc. | DualXS Fixed ACME Drawbar Long | 2023-08-18 |
| Amplify Surgical, Inc. | DualXS Inserter Outer Shaft Long | 2023-08-18 |
| Amplify Surgical, Inc. | DualXS Implant Retainer Shaft Long | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX TUBE RETRACTOR 18 X 160MM | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX TUBE RETRACTOR 18 X 150MM | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX TUBE RETRACTOR 18 X 120MM | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX TUBE RETRACTOR 18 X 110MM | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX TUBE RETRACTOR 18 X 100MM | 2023-08-18 |
| Amplify Surgical, Inc. | DualX SLAP HAMMER BARBELL | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX SCREW DRIVER 2 | 2023-08-18 |
| Amplify Surgical, Inc. | DualXS IMPLANT HOLDER | 2023-08-18 |
| Amplify Surgical, Inc. | DualX SLAP HAMMER ADAPTER | 2023-08-18 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SUCTION TUBE W/ STYLET | 2023-08-18 |
| Amplify Surgical, Inc. | DualX Fixed Drawbar T/PLIF Short | 2023-08-17 |
| Amplify Surgical, Inc. | DUALXS T/PLIF 15 DEG x 8-11MM | 2023-07-17 |
| Amplify Surgical, Inc. | DUALXS T/PLIF 8 DEG x 7-9MM | 2023-07-17 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SQUIRE CURETTE UP | 2023-06-08 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SQUIRE CURETTE RIGHT | 2023-06-08 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SQUIRE CURETTE LEFT | 2023-06-08 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SERIAL DILATOR #9 | 2023-06-08 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SERIAL DILATOR #7 | 2023-06-08 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SERIAL DILATOR #5 | 2023-06-08 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL DOUBLE ENDED DISSECTOR 5.0mm | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL DOUBLE ENDED DISSECTOR 4.0mm | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL DOUBLE ENDED DISSECTOR 3.0mm | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL DOUBLE ENDED DISSECTOR 2.0mm | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SERIAL DILATOR #9 | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SERIAL DILATOR #7 | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SERIAL DILATOR #5 | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL MUSCLE DETACHER | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL SPADE KNIFE | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL eX CAGE GUIDE | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL BALL HOOK | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL PITUITARY STRAIGHT 2.0mm | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX IMPLANT STERILIZATION CADDY | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL CANNULA 80MM | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL CANNULA 90MM | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL CANNULA 80MM | 2022-11-28 |
| Amplify Surgical, Inc. | DualX IMPLANT HOLDER | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL MICRO PITUITARY UP 2.0mm | 2022-11-28 |
| Amplify Surgical, Inc. | DUALX DUAL PORTAL MICRO PITUITARY STRAIGHT 2.0mm | 2022-11-28 |
Amplify Surgical, Inc. | DualX | 2021-09-29 |
Amplify Surgical Inc | DualX Lumbar Intervertebral Body Fusion Device | 2019-10-15 |
AMPLIFY SURGICAL INC. | DualX | 2018-12-10 |