510(k) K200995 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Insignia Anterior Cervical Plate System
| Applicant | Alphatec Spine, Inc., Carlsnad CA, US |
| Decision | Substantially Equivalent, May 21, 2020 |
| Received | Apr 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200995
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705 Terminated |
KWQ | None listed |
| Apr 26, 2021 | Alphatec Spine, Inc. Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712 Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.