Permitted scope,
at a glance.
13 medical device categories, summarized from the supplied attachment. Refer to the complete, valid QMS approval documents for the official scope.
TFDA QMS Categories
Filter by product category. Names and activities were transcribed from the supplied document images.
| NO. | Product image | Permitted category | Activities | Category |
|---|---|---|---|---|
| 01 |  | Burr hole cover (sterile) | Design, manufacturing, packaging, labeling and final release | Craniofacial and Neurosurgery |
| 02 |  | Preformed adjustable cranioplasty plate (sterile) | Design, manufacturing, packaging, labeling and final release | Craniofacial and Neurosurgery |
| 03 |  | Cranioplasty plate fixation device (sterile) | Design, manufacturing, packaging, labeling and final release | Craniofacial and Neurosurgery |
| 04 |  | Surgical mesh (sterile) | Design, manufacturing, packaging, labeling and final release | Craniofacial and Neurosurgery |
| 05 |  | Non-powered neurosurgical instrument (sterile) | Design, manufacturing, packaging, labeling and final release | Craniofacial and Neurosurgery |
| 06 |  | Manual orthopedic surgical instrument (sterile) | Design, manufacturing, packaging, labeling and final release | Orthopedics and Spine |
| 07 |  | Bone plate (sterile) | Design, manufacturing, packaging, labeling and final release | Orthopedics and Spine |
| 08 |  | Bone fixation screw or wire (sterile) | Design, manufacturing, packaging, labeling and final release | Orthopedics and Spine |
| 09 |  | Single or multiple metallic bone fixation devices and accessories (sterile) | Design, manufacturing, packaging, labeling and final release | Orthopedics and Spine |
| 10 |  | Intervertebral spinal fixation device (sterile) | Design, manufacturing, packaging, labeling and final release | Orthopedics and Spine |
| 11 |  | Medical face mask | Design, packaging, labeling and final release | Other Devices |
| 12 |  | Interlaminar spinal fixation device (sterile) | Design, packaging, labeling and final release | Orthopedics and Spine |
| 13 |  | Passive tendon prosthesis (sterile) | Design, manufacturing, packaging, labeling and final release | Other Devices |
Product images help identify categories. Actual design, specifications and approval documents are project-specific.
Actual scope, product specifications and regulatory applicability are subject to complete, valid approval documents and project review. A QMS manufacturing scope is not an individual product's marketing authorization.Sports medicine projects require product-specific classification review ↗
Prepare product requirements before starting.
Intended use, drawings, materials, critical specifications, requested activities and schedule provide a starting point for project evaluation. Contact OSSAWARE through its published business email.