# K171250: BRIDALVEIL Occipital Cervical Thoracic System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Oct 2, 2017 after 157 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K853033 (1985). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143471: VERTEX Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K152338: VERTEX (r) Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K150474: NuVasive VuePoint II OCT System, Nu Vasive, Incorporated (2015) Summary page 4.
- K153336: VuePoint OCT System, Nu Vasive, Incorporated (2016) Summary page 4.
- K153631: Zimmer Virage OCT Spinal Fixation System, Zimmer Spine, Inc. (2016) Summary page 4.
- K150650: neon3, Ulrich GmbH & Co. KG (2015) Summary page 4.
- K073654: Blackstone Ascent Poct System Parallel Rod Connector, Blackstone Medical, Inc. (2008) Summary page 4.

## Most influential descendants
- K220570: M.U.S.T. MINI Posterior Cervical Screws System Extension (2022), 0 descendants of its own

## Indications for use
The BRIDALVEIL Occipital Cervical Thoracic System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the BRIDALVEIL Occipital Cervical Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.

Source page: https://510kreport.com/device/K171250
Methodology: https://510kreport.com/methodology