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Sign in to claim this brandParadigm Spine, LLC
US
Last updated May 23, 2026
What Paradigm Spine, LLC makes
Paradigm Spine, LLC produces reusable orthopaedic instruments for spinal and pelvic procedures, including positioning tools for prosthesis implantation and fixation systems for sacroiliac joints. Their portfolio includes dynamic spinal stabilization devices, interspinous fixation implants, and lumbar decompression spacers, as well as non-bioabsorbable internal fixation plates and screws. Additional offerings include reusable sterilization/disinfection containers and surgical instrument racks for implant organization.
The company’s devices span FDA Class I, II, and III classifications, with all 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 Paradigm Spine, LLC manufacture?
Paradigm Spine, LLC specializes in orthopaedic devices primarily focused on spinal and pelvic procedures. Their product line includes reusable orthopaedic instruments like positioning tools for prosthesis implantation, as well as fixation systems for sacroiliac joints. They also produce dynamic spinal stabilization systems, interspinous fixation implants, lumbar decompression spacers, and non-bioabsorbable internal fixation plates and screws. Additionally, the company offers reusable sterilization/disinfection containers and surgical instrument racks to organize implants.
Where is Paradigm Spine, LLC based?
Paradigm Spine, LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and distribution logistics, particularly for devices subject to FDA requirements.
Which regulatory registries or databases list Paradigm Spine, LLC’s devices?
All of Paradigm Spine, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, helping healthcare providers and regulators identify and verify specific devices.
How are Paradigm Spine, LLC’s devices classified by the FDA?
Paradigm Spine, LLC’s devices span three FDA risk classifications: Class I (low-risk, general controls), Class II (moderate-risk, requiring special controls), and Class III (high-risk, requiring premarket approval). The classification depends on the device’s intended use and potential risk to patients, with higher-risk devices requiring stricter regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (466)
Page 7 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DSS™ Implant Guide | DAT40411 | FDA UDI | Class I | Active |
| DSS, Measuring adapter with k-wire | DAT30425 | FDA UDI | Class I | Active |
| DSS HP Polyaxial pedicle screw set, Ø6 x 40mm | HPI86040 | FDA UDI | Class II | Active |
| DSS Pedicle screw set, Ø7.0 x 30mm | DPI57030 | FDA UDI | Class II | Active |
| DSS™ Caliper, Adapter Bottom | DAT30410 | FDA UDI | Class I | Active |
| HPS Inserter, short | HAT80165 | FDA UDI | Class I | Active |
| SImmetry LAG Implant, 14.5mm x 60mm | 10-PL14560-01 | FDA UDI | Class II | Active |
| SImmetry, Ratcheting Extended Offset T-Handle | ZYG-10089 | FDA UDI | Class II | Active |
| DSS Pedicle screw set, Ø6.0 x 45mm | DPI46045 | FDA UDI | Class II | Active |
| DSS™ Measuring adapter, clip | DAT30441 | FDA UDI | Class I | Active |
| DSS™ Reamer | DAT40300 | FDA UDI | Class I | Active |
| SImmetry Washer, 14.5mm Implant | 10-W14500-01 | FDA UDI | Class II | Active |
| SImmetry LAG Implant, 12.5mm x 85mm | 10-PL12585-01 | FDA UDI | Class II | Active |
| DSS Pedicle screw set, Ø8.0 x 50mm | DPI48050 | FDA UDI | Class II | Active |
| SImmetry, Pin Guide Insert | ZYG-10136-2 | FDA UDI | Class II | Active |
| DSS HP Polyaxial pedicle screw set, Ø6 x 45mm | HPI86045 | FDA UDI | Class II | Active |
| HPS Pedicle Probe | HAT50302 | FDA UDI | Class I | Active |
| DSS™ tap with sharp tip 8mm | DAT40282 | FDA UDI | Class I | Active |
| SImmetry Implant, 8.5mm x 60mm | 10-S08560-01 | FDA UDI | Class II | Active |
| DSS™ Nut inserter | DAT00405 | FDA UDI | Class I | Active |
| SImmetry Implant, 10.5mm x 65mm | 10-S10565-01 | FDA UDI | Class II | Active |
| SImmetry Implant, 14.5mm x 100mm | 10-P145100-01 | FDA UDI | Class II | Active |
| SImmetry, 17mm Sleeve | ZYG-10077 | FDA UDI | Class II | Active |
| SImmetry Implant, 8.5mm x 105mm | 10-S085105-01 | FDA UDI | Class II | Active |
| DSS™ Tap for Screw 5mm | DAT40250 | FDA UDI | Class I | Active |
| coflex Interlaminar Technology, US, Size 14 | UPI00014 | FDA UDI | Class III | Active |
| SImmetry LAG Implant, 8.5mm x 100mm | 10-SL085100-01 | FDA UDI | Class II | Active |
| HPS Trocar | HAT50102 | FDA UDI | Class I | Active |
| DSS Rigid eye connector set, straight, 130mm | DPI92113 | FDA UDI | Class II | Active |
| SImmetry LAG Implant, 12.5mm x 50mm | 10-PL12550-01 | FDA UDI | Class II | Active |
| SImmetry Implant, 12.5mm x 35mm | 10-P12535-01 | FDA UDI | Class II | Active |
| coflex trial with guide and x-ray marker, 16mm | UXT10016 | FDA UDI | Class III | Active |
| DSS Pedicle screw set, Ø8.0 x 35mm | DPI58035 | FDA UDI | Class II | Active |
| DSS Pedicle screw set, Ø5.0 x 35mm | DPI45035 | FDA UDI | Class II | Active |
| DSS HP Set screw set | HPI81010 | FDA UDI | Class II | Active |
| DSS™ Caliper, Adapter Fixation | DAT30430 | FDA UDI | Class I | Active |
| SImmetry Implant, 12.5mm x 70mm | 10-P12570-01 | FDA UDI | Class II | Active |
| SImmetry LAG Implant, 8.5mm x 80mm | 10-SL08580-01 | FDA UDI | Class II | Active |
| CoFix Implant 12 mm | RQI00012 | FDA UDI | Class II | Active |
| SImmetry LAG Implant, 12.5mm x 55mm | 10-PL12555-01 | FDA UDI | Class II | Active |
| DSS HP Polyaxial pedicle screw set, Ø8 x 60mm | HPI88060 | FDA UDI | Class II | Active |
| SImmetry Implant, 14.5mm x 95mm | 10-P14595-01 | FDA UDI | Class II | Active |
| DSS HP Polyaxial pedicle screw set, Ø5 x 60mm | HPI85060 | FDA UDI | Class II | Active |
| DSS Slotted coupler, 50N/mm stiffness, 31mm long | DPI35031 | FDA UDI | Class II | Active |
| DSS Pedicle screw set, Ø6.0 x 50mm | DPI46050 | FDA UDI | Class II | Active |
| SImmetry LAG Implant, 8.5mm x 90mm | 10-SL08590-01 | FDA UDI | Class II | Active |
| DSS™ Screw Extractor | DAT40190 | FDA UDI | Class I | Active |
| SImmetry Implant, 12.5mm x 75mm | 10-P12575-01 | FDA UDI | Class II | Active |
| DSS™ Protection sleeve | DAT40200 | FDA UDI | Class I | Active |
| SImmetry, Graft Inserter, Straight | ZYG-10135 | FDA UDI | Class II | Active |
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