Identity
- Trade Name
- BAK INTERBODY FUSION SYSTEM FDA PMA
- Generic Name
- Intervertebral fusion device with bone graft, lumbar FDA PMA
Identifiers
- PMA Number
- P950002 FDA PMA
- FDA Product Code
- MAX FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 888.3080 FDA PMA
- Regulation Number
- 888.3080 FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APRL FDA PMA
The BAK Interbody Fusion System is an intervertebral fusion device designed for lumbar spine applications, intended to facilitate spinal stabilization and fusion through the placement of bone graft material between vertebral bodies. Constructed as a cage-like structure, it provides structural support while promoting bony fusion, addressing degenerative disc disease, spinal instability, or deformity in the lumbar region.
This system is supplied sterile and intended for single-use, requiring surgical implantation via an anterior or posterior approach. It is approved for use in the United States under an FDA Premarket Approval (PMA) with PMA number P950002. The device is categorized under product code MAX and is regulated as a Class III medical device, adhering to strict manufacturing and performance standards.
Frequently asked questions
What types of spinal conditions is the BAK/L Interbody Fusion System specifically designed to address in the lumbar spine?
The BAK/L Interbody Fusion System is designed to address degenerative disc disease, spinal instability, or deformity in the lumbar region. It provides structural support and facilitates bony fusion by placing bone graft material between vertebral bodies, helping stabilize the spine during recovery.
Is the BAK/L Interbody Fusion System intended for use in both anterior and posterior surgical approaches?
Yes, the BAK/L Interbody Fusion System is approved for surgical implantation via either an anterior or posterior approach. This flexibility allows surgeons to choose the most appropriate access method based on the patient’s anatomy and clinical needs.
How is the BAK/L Interbody Fusion System supplied, and is it reusable?
The BAK/L Interbody Fusion System is supplied sterile and is explicitly intended for single-use only. This ensures patient safety and maintains device integrity, as reuse is not supported by the manufacturer’s design or regulatory approval.
What regulatory pathway was followed for FDA approval of the BAK/L Interbody Fusion System?
The BAK/L Interbody Fusion System received FDA approval through the Premarket Approval (PMA) process, with PMA number P950002. This pathway is required for Class III devices, which are subject to strict scrutiny to ensure safety and effectiveness before market authorization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P950002 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Spine, Inc.
Sources (1)
- FDA PMA P950002 24 fields · synced Sep 18, 2026