BAK/Cervical Interbody Fusion System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Bak/Cervical (Bak/C) (R) Interbody Fusion System

Trade Name

Bak/Cervical (Bak/C) Interbody Fusion System

Generic Name

Intervertebral fusion device with bone graft, lumbar

PMA Number

P980048 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

APRL

• Silhouette Spinal Fixation System Modification

  Class II

  FDA 510(k) K992276 Active Cleared 1 Oct 1999

• Silhouette Spinal Fixation System

  Class II

  FDA 510(k) K993067 Active Cleared 16 Nov 1999

• Cadence Spinal Fixation System

  Class II

  FDA 510(k) K022374 Active Cleared 24 Sep 2002

• Modification to Silhouette Spinal Fixation System

  Class II

  FDA 510(k) K020196 Active Cleared 15 Feb 2002

• Modification to: Trinica Anterior Cervical Plate System

  Class II

  FDA 510(k) K012305 Active Cleared 22 Aug 2001

• Device Modification of Silhouette Spindal Fixation System

  Class II

  FDA 510(k) K012173 Active Cleared 28 Sep 2001

See all devices from Sulzer Spine-Tech →

• What cervical spine levels is the BAK/Cervical Interbody Fusion System approved for use in patients with degenerative disc disease and radicular symptoms?

  The BAK/Cervical Interbody Fusion System is approved for use at the C-3 to C-7 disc levels in skeletally mature patients with degenerative disc disease (DDD) and accompanying radicular symptoms at a single disc level. This is based on the device’s intended use as described in the advisory committee statement and PMA authorization.

• How is the BAK/Cervical Interbody Fusion System supplied, and is it reusable?

  The BAK/Cervical Interbody Fusion System is supplied sterile and is intended for single-use only. Since it is designed for surgical implantation and sterilized for one-time use, reuse is not recommended or supported by the manufacturer or regulatory approval.

• What surgical approach is required to implant the BAK/Cervical Interbody Fusion System, and what additional materials are needed?

  The BAK/Cervical Interbody Fusion System is placed via an anterior surgical approach at the specified cervical disc levels. The device is intended to be used in conjunction with autograft bone to facilitate spinal fusion, as outlined in the device description and advisory committee statement.

• How should the BAK/Cervical Interbody Fusion System be stored, and what precautions should be taken?

  The BAK/Cervical Interbody Fusion System must be stored and handled according to sterile surgical instrument protocols to maintain its sterility. Since it is supplied sterile, proper packaging integrity and adherence to manufacturer instructions are critical to prevent contamination before use.