510(k) K121060 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SPINE FRONTIER INDUS ACP SYSTEM
| Applicant | Spinefrontier, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Jul 3, 2012 |
| Received | Apr 6, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | None listed |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | None listed |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | None listed |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | None listed |
| Aug 13, 2013 | SpineFrontier, Inc. Invue Solid Driver, Tipped, AO. Part Number: 11-70083.
Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. Terminated |
HXX | None listed |
| Aug 8, 2013 | SpineFrontier, Inc. Indus Invue Screw Caddy, Model: SI70097
The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates t Terminated |
FSM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.