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Sign in to claim this brandZsfab, Inc.
US
Last updated May 23, 2026
What Zsfab, Inc. makes
Zsfab, Inc. manufactures metallic spinal interbody fusion cages and associated surgical instruments, including systems for cervical and lumbar spinal procedures. These devices are designed for interbody fusion and surgical stabilization in the cervical and lumbar regions of the spine.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Zsfab, Inc. manufacture?
Zsfab, Inc. specializes in metallic spinal interbody fusion cages and associated surgical instruments. These devices are primarily used for spinal fusion and stabilization in the cervical (neck) and lumbar (lower back) regions of the spine. The company’s portfolio focuses on products designed to support surgical procedures aimed at improving spinal alignment and promoting bone fusion.
Where is Zsfab, Inc. based, and what does that mean for its regulatory oversight?
Zsfab, Inc. is based in the United States, which means its devices are subject to FDA regulations. The FDA classifies the company’s products as either Class I or Class II, depending on their risk level and intended use. This classification determines the regulatory pathway for authorization, such as 510(k) clearance for Class II devices.
Are Zsfab, Inc.’s devices listed in any regulatory registries, and why does this matter?
Yes, Zsfab, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to verify the identity and authorization status of the devices. It also supports post-market surveillance and compliance efforts.
How are Zsfab, Inc.’s devices classified under FDA regulations, and what does that classification indicate?
Zsfab, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may require general controls for authorization, while Class II devices involve moderate risk and typically require premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. The classification reflects the level of scrutiny and regulatory oversight needed to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 105224126
Catalogue (523)
Page 1 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ZSFab Cervical Surgical Instrument | 14160815 | FDA UDI | Class I | Active |
| ZSFab Lumbar Interbody System | 28101400 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 28101104 | FDA UDI | Class II | Active |
| ZSFab Cervical Surgical Instrument | 16180707 | FDA UDI | Class I | Active |
| ZSFab Lumbar Interbody System | 24101100 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 14161100 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 16181115 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 14160500 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 16180910 | FDA UDI | Class II | Active |
| ZSFab Cervical Surgical Instrument | 12141015 | FDA UDI | Class I | Active |
| ZSFab Lumbar Surgical Instrument | Nerve Root Retractor-10mm | FDA UDI | Class I | Active |
| ZSFab Cervical Interbody System | 16180815R | FDA UDI | Class II | Active |
| ZSFab Cervical Surgical Instrument | 14160507 | FDA UDI | Class I | Active |
| ZSFab Lumbar Interbody System | 28101306 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 31121308 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 16180607 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 28101004 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 14160715R | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 12140700R | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 28101408 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 24100800 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 28100804 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 14161207R | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 31121108 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 14161107 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 28100906 | FDA UDI | Class II | Active |
| ZSFab Lumbar Surgical Instrument | Cage Inserter Caddy | FDA UDI | Class I | Active |
| ZSFab Lumbar Interbody System | 28101300 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 14161207 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 28100906 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 31121404 | FDA UDI | Class II | Active |
| ZSFab Cervical Surgical Instrument | 16180815 | FDA UDI | Class I | Active |
| ZSFab Cervical Interbody System | 16181007R | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 14160810R | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 12141215R | FDA UDI | Class II | Active |
| ZSFab Cervical Surgical Instrument | 14161020 | FDA UDI | Class I | Active |
| ZSFab Cervical Surgical Instrument | 16181107 | FDA UDI | Class I | Active |
| ZSFab Cervical Surgical Instrument | Disc wedge 2 | FDA UDI | Class I | Active |
| ZSFab Cervical Interbody System | 12141110R | FDA UDI | Class II | Active |
| ZSFab Lumbar Surgical Instrument | Ring Graft Impactor | FDA UDI | Class I | Active |
| ZSFab Cervical Interbody System | 16181015R | FDA UDI | Class II | Active |
| ZSFab Cervical Surgical Instrument | 16180607 | FDA UDI | Class I | Active |
| ZSFab Lumbar Surgical Instrument | Paddle Distractor-10mm | FDA UDI | Class I | Active |
| ZSFab Cervical Interbody System | 14161020 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 28100800 | FDA UDI | Class II | Active |
| ZSFab Cervical Surgical Instrument | Cage Inserter(with Stopper) | FDA UDI | Class I | Active |
| ZSFab Cervical Interbody System | 14161220R | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 16181015 | FDA UDI | Class II | Active |
| ZSFab Cervical Interbody System | 16180700 | FDA UDI | Class II | Active |
| ZSFab Lumbar Interbody System | 24100906 | FDA UDI | Class II | Active |
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