FDA 510(k) Applications Submitted by ERIC LIN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K151211 |
05/06/2015 |
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup |
Assure Tech. Co., Ltd |
| K152025 |
07/22/2015 |
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
ASSURE TECH. CO., LTD. |
| K152768 |
09/24/2015 |
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip |
ASSURE TECH. CO., LTD. |
| K210402 |
02/10/2021 |
Curiteva Sacroiliac Joint Fusion System |
Curiteva, Inc. |
| K231232 |
04/28/2023 |
Curiteva Laminoplasty System |
Curiteva, Inc. |
| K181261 |
05/11/2018 |
Curiteva Cervical Interbody Fusion System |
Curiteva, LLC |
| K181549 |
06/12/2018 |
Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) |
Curiteva, LLC |
| K181562 |
06/14/2018 |
Curiteva Anterior Cervical Plate System |
Curiteva, LLC |
| K181589 |
06/18/2018 |
Curiteva Lumbar Interbody Fusion System |
Curiteva, LLC |
| K191810 |
07/05/2019 |
Curiteva Pedicle Screw System |
Curiteva, Inc. |
| K213030 |
09/21/2021 |
Curiteva Porous PEEK Cervical Interbody Fusion System |
Curiteva, Inc. |
| K223200 |
10/13/2022 |
Curiteva Navigation System |
Curiteva, Inc. |
| K992916 |
08/30/1999 |
BRAINLAB STEREOTACTIC ARC |
BRAINLAB |
| K983660 |
10/19/1998 |
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) |
BRAINLAB, INC. |
| K190365 |
02/15/2019 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
| K190586 |
03/06/2019 |
Monster« Screw System |
Paragon 28, Inc. |
| K191227 |
05/07/2019 |
Paratrooper Plantar Plate Repair System |
Paragon 28, Inc. |
| K191782 |
07/02/2019 |
TTC Phantom Intramedullary Nail System |
Paragon 28, Inc. |
| K182148 |
08/08/2018 |
SILVERBACK Gorilla Plating System |
Paragon 28, Inc. |
| K182307 |
08/24/2018 |
Small Bone Phantom« Intramedullary Nail System; TTC Phantom« Intramedullary Nail System |
Paragon 28, Inc |
| K172886 |
09/21/2017 |
Breakaway Screw System |
Paragon 28 |
| K182898 |
10/16/2018 |
TenoTac Soft Tissue Fixation System |
Paragon 28, Inc |
| K192994 |
10/25/2019 |
Paragon 28 APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
| K133475 |
11/12/2013 |
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS |
NEXXT SPINE LLC |
| K183228 |
11/20/2018 |
HammerToe Compression System |
Paragon 28, Inc. |
| K183690 |
12/31/2018 |
Tenodesis Screw System |
Paragon 28,Inc. |
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