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Implanet

US

Last updated May 23, 2026

What Implanet makes

Implanet manufactures spinal fixation devices, including trans-facet screws, internal fixation rods, polymeric interbody fusion cages, and cable tensioners for spinal stabilization. Their portfolio also includes cruciate-retaining total knee prostheses, orthopaedic surgical kits, and reusable instrument trays for orthopaedic procedures.

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. Implanet 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 Implanet manufacture?

Implanet specializes in spinal and orthopaedic devices. Their portfolio includes systems for spinal stabilization like trans-facet screws, internal spinal fixation rods, polymeric interbody fusion cages, and cable tensioners. They also produce cruciate-retaining total knee prostheses, reusable orthopaedic surgical kits, and instrument trays designed for orthopaedic procedures. These devices are primarily used in spinal and joint surgeries to provide structural support and promote healing.

Where is Implanet based?

Implanet is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA). This means their devices must adhere to FDA guidelines and regulations for classification, listing, and post-market surveillance.

Which regulatory registries list Implanet’s devices?

Implanet’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and helps ensure traceability, regulatory compliance, and transparency in the healthcare system. Listing in this database is required for Class I and Class II devices in the U.S.

How are Implanet’s devices classified by the FDA?

Implanet’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and are typically exempt from premarket notification (510(k)) requirements, while Class II devices require special controls to ensure their 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 or joint stabilization.

Why does the classification of Implanet’s devices matter?

The FDA classification determines the regulatory pathway a device must follow before it can be marketed. For example, Class II devices like some of Implanet’s spinal fixation systems require premarket submissions to demonstrate compliance with FDA regulations, ensuring they meet performance standards and safety requirements. This classification helps healthcare providers and regulators assess the risk associated with the device, influencing how it is used in clinical settings and monitored post-market.

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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LinkedIn
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Facebook
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Email
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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
291993439

Catalogue (1134)

Page 13 of 23
DeviceModel / ReferenceRegistriesClassStatus
Madison Tibial trial baseplate - S2
FDA UDI
Class IIActive
Implanet Spine System Dual Polyaxial Screw
FDA UDI
Class IIActive
JAZZ System Tensioner Gen.II -Stem 3,5-4mm
FDA UDI
Class IIActive
Madison UC insert trial size 6 - 14mm
FDA UDI
Class IIActive
Implanet Spine System Monoaxial Pedicle Screw
FDA UDI
Class IIActive
JAZZ System Jazz Rod - Pre-bent Union Rod – L70
FDA UDI
Class IIActive
Madison Container base set 6
FDA UDI
Class IActive
JAZZ Systems JAZZ CLAW –Snapping Forceps
FDA UDI
Class IIActive
JAZZ System JAZZ CLAW -Hook Trial Large Left
FDA UDI
Class IIActive
Implanet Spine System Straight Union Rod
FDA UDI
Class IIActive
JAZZ System JAZZ Band
FDA UDI
Class IIActive
Implanet Spine System Straight Union Rod CoCr
FDA UDI
Class IIActive
Implanet Spine System Prebent Union Rod
FDA UDI
Class IIActive
Implanet Spine System In-situ Bender Ø6.0 - Left
FDA UDI
Class IActive
Implanet Spine System Straight Union Rod
FDA UDI
Class IIActive
Madison CR Femoral EVO trial - S3 / Left
FDA UDI
Class IIActive
JAZZ System Jazz Screw - Monoaxial Screw Dia.7 L60
FDA UDI
Class IIActive
Madison Madison BL Spacer Plate 14mm
FDA UDI
Class IActive
Implanet Spine System Straight Union Rod
FDA UDI
Class IIActive
Implanet Spine System Straight Union Rod
FDA UDI
Class IIActive
Implanet Spine System Polyaxial Pedicle Screw
FDA UDI
Class IIActive
Implanet Spine System Straight Union Rod
FDA UDI
Class IIActive
Implanet Spine System Straight Union Rod CoCr
FDA UDI
Class IIActive
JAZZ System Straight Passer – 20mm
FDA UDI
Class IIActive
JAZZ System Connector Kit
FDA UDI
Class IIActive
Implanet Spine System Monoaxial Pedicle Screw
FDA UDI
Class IIActive
JAZZ System JAZZ Evo – 5mm Connector Kit
FDA UDI
Class IIActive
JAZZ System Jazz Screw - Monoaxial Screw Dia.7 L35
FDA UDI
Class IIActive
Madison Madison Quick-connect twisted pin L2
FDA UDI
Class IActive
JAZZ System JAZZ CLAW-Hook Trial Left
FDA UDI
Class IIActive
Implanet Spine System Prebent Union Rod
FDA UDI
Class IIActive
Implanet Spine System Straight Union Rod CoCr
FDA UDI
Class IIActive
Jazz Frame JAZZ Frame - T-Bar Dia.4,5 L35
FDA UDI
Class IIActive
Implanet Spine System Straight Union Rod
FDA UDI
Class IIActive
Implanet Spine System Polyaxial Pedicle Screw
FDA UDI
Class IIActive
Madison Universal UC insert Size 3 - 14 mm
FDA UDI
Class IIActive
Implanet Spine System Monoaxial Pedicle Screw
FDA UDI
Class IIActive
JAZZ System JAZZ CLAW-Hook Trial Large Right
FDA UDI
Class IIActive
Implanet Spine System Offset Rod to Rod Connector
FDA UDI
Class IIActive
JAZZ System Open braid
FDA UDI
Class IIActive
Madison Universal UC insert Size 5 - 18 mm
FDA UDI
Class IIActive
Madison 8mm rod adapter
FDA UDI
Class IActive
Madison Madison BL Base
FDA UDI
Class IActive
JAZZ System Instruments Container Gen.II - Basis
FDA UDI
Class IActive
Madison Tibial stem Ø13 mm length 95 mm
FDA UDI
Class IIActive
Madison Universal UC insert Size 8 - 12 mm
FDA UDI
Class IIActive
Implanet Spine System Dual Pedicular Hook, Short Blade
FDA UDI
Class IIActive
Implanet Spine System Dual Compressor
FDA UDI
Class IActive
Implanet Spine System Straight Union Rod
FDA UDI
Class IIActive
Implanet Spine System Prebent Union Rod
FDA UDI
Class IIActive

Related Companies

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Implanet Martillac Nouvelle-Aquitaine · FR FEI 3007675554