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Sign in to claim this brandZIMMER SPINE, INC.
US
Last updated May 24, 2026
What ZIMMER SPINE, INC. makes
Zimmer Spine manufactures spinal fixation devices, including non-sterile bone-screw systems, reusable orthopaedic surgical kits, and non-bioabsorbable spinal plates. Their portfolio also includes metallic interbody fusion cages, internal distractors, reusable bone taps, and trial implants for spinal procedures. Specific products like the Sequoia®, Nex-Link®, and Instinct™ Java® System are designed for internal orthopaedic fixation and spinal stabilization.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are regulated under U.S. medical device laws, adhering to applicable standards for spinal implants and orthopaedic fixation systems. The manufacturer operates from 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 Zimmer Spine, Inc. manufacture?
Zimmer Spine, Inc. specializes in spinal fixation and orthopaedic devices. Their portfolio includes non-sterile bone-screw internal spinal fixation systems, reusable orthopaedic surgical kits, non-bioabsorbable spinal plates, metallic spinal interbody fusion cages, internal distractors, reusable bone taps, and spinal implant trials. These products are designed for spinal stabilization, internal fixation, and orthopaedic procedures, such as fusion and distraction.
Where is Zimmer Spine, Inc. based, and how does that affect its regulatory standing?
Zimmer Spine, Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under FDA’s Class I and Class II categories. This means their products must comply with U.S. medical device laws and standards, ensuring safety, performance, and proper labeling before entering the market.
Which regulatory registries or databases list Zimmer Spine, Inc.’s devices?
Zimmer Spine, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
How are Zimmer Spine, Inc.’s devices classified under FDA regulations?
Zimmer Spine, Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as spinal fixation systems.
What is the purpose of devices like the Sequoia® or Nex-Link® in Zimmer Spine’s portfolio?
Devices like the Sequoia® and Nex-Link® are part of Zimmer Spine’s portfolio of spinal fixation systems. These products are designed for internal orthopaedic fixation, providing stability to the spine during procedures such as spinal fusion or stabilization. They typically include components like screws, plates, or cages to support bone alignment and healing while minimizing movement.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zimmerbiomet.com
- —
- —
- [email protected]
- Phone
- +1(866)774-6368
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 787663400
Catalogue (2565)
Page 2 of 52| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| InFix® Anterior Lumbar System | 1850-4200 | FDA UDI | Class II | Active |
| Instinct™ Java® System | 046W0AN25525 | FDA UDI | Class II | Active |
| Instinct® Java™ System | 046W2AN00073 | FDA UDI | Class II | Active |
| Instinct™ Java® System | 046W0AN65540 | FDA UDI | Class II | Active |
| InCompass® | 2212-40 | FDA UDI | Class II | Active |
| St360°® | 07.01084.003 | FDA UDI | Class II | Active |
| InCompass® | 2103-7590 | FDA UDI | Class II | Active |
| Instinct™ Java® System | 046W0AN20020 | FDA UDI | Class II | Active |
| InCompass® | 9206-125 | FDA UDI | Class II | Active |
| Instinct™ | 046W0AN00331 | FDA UDI | Class II | Active |
| Vitality® | 07.02114.010 | FDA UDI | Class II | Active |
| Nex-Link OCT® | 7004-3518 | FDA UDI | Class II | Active |
| TiTLE® | 500-5020 | FDA UDI | Class II | Active |
| Ardis® | 3254-150922 | FDA UDI | Class II | Active |
| Instinct™ Java® System | 046W0AN76015 | FDA UDI | Class II | Active |
| ThinLine® | 402-46012 | FDA UDI | Class II | Active |
| Universal Clamp ™ | SNA027-0-20000 | FDA UDI | Class II | Active |
| Trinica® Trinica® | 07.00811.010 | FDA UDI | Class II | Active |
| Dynesys® | 07.01294.001 | FDA UDI | Class II | Active |
| Trinica® | 07.01008.003 | FDA UDI | Class II | Active |
| Sequoia® | 3306-5530 | FDA UDI | Class II | Active |
| inViZia® | 07.01615.007 | FDA UDI | Class II | Active |
| Trinica® | 07.01011.003 | FDA UDI | Class II | Active |
| Trinica® Trinica® | 07.00811.006 | FDA UDI | Class II | Active |
| SlimLine® | 403-3059 | FDA UDI | Class II | Active |
| Vitality® | 07.02088.004 | FDA UDI | Class II | Active |
| St360°® | 07.00401.012 | FDA UDI | Class II | Active |
| Instinct® Java™ System | 046W2AN00071 | FDA UDI | Class II | Active |
| St360°® | 07.00292.007 | FDA UDI | Class II | Active |
| V2f™ | 07.01657.011 | FDA UDI | Class II | Active |
| Vitality® | 07.02067.001 | FDA UDI | Class I | Active |
| SlimLine® | 403-2054 | FDA UDI | Class II | Active |
| Vitality® | 07.02088.013 | FDA UDI | Class II | Active |
| Trinica® | 07.01010.006 | FDA UDI | Class II | Active |
| PathFinder NXT® | 3573-10 | FDA UDI | Class II | Active |
| Ardis® | 3201-111134 | FDA UDI | Class II | Active |
| Trinica® Trinica® | 07.00811.014 | FDA UDI | Class II | Active |
| TiTLE® | 800-7045 | FDA UDI | Class II | Active |
| Trinica® | 07.01011.007 | FDA UDI | Class II | Active |
| SlimLine® | 403-2140 | FDA UDI | Class II | Active |
| Instinct™ | 046W0AN47560 | FDA UDI | Class II | Active |
| InCompass® | 2105-6545 | FDA UDI | Class II | Active |
| Trinica® | 07.01012.003 | FDA UDI | Class II | Active |
| TiTLE® | 535-5080 | FDA UDI | Class II | Active |
| Optio-C® | 07.01874.016 | FDA UDI | Class II | Active |
| St360°® | 07.00319.038 | FDA UDI | Class II | Active |
| TiTLE® | 800-6055 | FDA UDI | Class II | Active |
| inViZia® | 07.01615.003 | FDA UDI | Class II | Active |
| InCompass® | 2106-6545 | FDA UDI | Class II | Active |
| Optio-C® | 07.01899.001 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Zimmer Spine, Inc. has six recall records initiated between May 21, 2004, and February 12, 2016, all of which are marked as terminated. The reasons include updated instructions for cleaning and disinfecting specific systems (Instinct Java and Universal Clamp), a reported surgical case involving incorrect drill bit provision, potential breakage of recalled bone taps during use, a thread timing issue with ST360 Distal Thread Reduction Guide Pins, and additional guidance for the Virage OCT Spinal Fixation System.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 12, 2016 | Z-1190-2016 | — | terminated | Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001). |
| Feb 12, 2016 | Z-1189-2016 | — | terminated | Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001). |
| Feb 3, 2016 | Z-1019-2016 | — | terminated | Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual. |
| Oct 5, 2006 | Z-0190-2007 | — | terminated | Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing. |
| Aug 24, 2004 | Z-0040-05 | — | terminated | To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected. |
| May 21, 2004 | Z-1014-04 | — | terminated | The recalled bone taps could break inside the vertebral body during the tapping process. |