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Sign in to claim this brandInnovative Surgical Designs, Inc.
US
Last updated May 23, 2026
What Innovative Surgical Designs, Inc. makes
Innovative Surgical Designs, Inc. manufactures sterile bone-screw internal spinal fixation systems, including screw-based and tulip-style fixation components for spinal stabilization procedures.
Their products are regulated as Class II devices in the US, with records maintained in the FDA’s 510(k) and UDI registries. The company 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 Innovative Surgical Designs, Inc. manufacture?
Innovative Surgical Designs, Inc. specializes in sterile bone-screw internal spinal fixation systems. These devices are designed for spinal stabilization procedures and include screw-based and tulip-style fixation components, such as the True Spinal Fixation System and True Tulip Spinal Fixation System.
Where is Innovative Surgical Designs, Inc. based?
The company is headquartered in the United States. Its location is relevant for regulatory compliance and reporting purposes, particularly for devices regulated under US standards.
Which regulatory registries list Innovative Surgical Designs, Inc.’s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track Class II devices like Innovative Surgical Designs’ spinal fixation systems, ensuring transparency in their regulatory status.
How are Innovative Surgical Designs, Inc.’s devices classified under US regulations?
Innovative Surgical Designs, Inc.’s bone-screw internal spinal fixation systems are classified as Class II devices in the US. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (287)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| True Spinal Fixation System | 105-9-308-760 | FDA UDI | Class II | Active |
| True Tulip Spinal Fixation System | L-205-9-338-5050 | FDA UDI | Class II | Active |
| True Spinal Fixation System | L-105-9-338-5055 | FDA UDI | Class II | Active |
| True Spinal Fixation System | N-105-9-303-540 | FDA UDI | Class II | Active |
| True Spinal Fixation System | L-105-9-338-5085 | FDA UDI | Class II | Active |
| True Spinal Fixation System | N-105-9-303-537 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-302-525 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-302-880 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-339-501 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-320-510 | FDA UDI | Class II | Active |
| True Spinal Fixation System | L-105-9-338-5115 | FDA UDI | Class II | Active |
| True Tulip Spinal Fixation System | 205-9-308-545 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-308-880 | FDA UDI | Class II | Active |
| True Spinal Fixation System | N-105-9-303-050 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-308-735 | FDA UDI | Class II | Active |
| True Spinal Fixation System | N-105-9-303-030 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-339-510 | FDA UDI | Class II | Active |
| True Spinal Fixation System | N-105-9-303-065 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-308-645-TT | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-320-610 | FDA UDI | Class II | Active |
| True Tulip Spinal Fixation System | S-205-9-338-5115 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-302-A745 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-302-545 | FDA UDI | Class II | Active |
| True Tulip Spinal Fixation System | S-205-9-338-5050 | FDA UDI | Class II | Active |
| True Spinal Fixation System | 105-9-302-750 | FDA UDI | Class II | Active |
| True Tulip Spinal Fixation System | S-205-9-338-5350 | FDA UDI | Class II | Active |
| True Tulip Spinal Fixation System | S-205-9-338-5200 | FDA UDI | Class II | Active |
| True Tulip Spinal Fixation System | L-205-9-338-5085 | FDA UDI | Class II | Active |
| True Spinal Fussion System | K133690 | FDA 510(k) | Class II | Active |
| True Tulip, True M.I.S. | K210816 | FDA 510(k) | Class II | Active |
| True Tulip System, True M.I.S. System | K201780 | FDA 510(k) | Class II | Active |
| Redi-Spine | K181584 | FDA 510(k) | Class II | Active |
| True Spinal Fixation System | K171559 | FDA 510(k) | Class II | Active |
| True Spinal Fixation System | K170710 | FDA 510(k) | Class II | Active |
| True Spinal Fixation System | K130958 | FDA 510(k) | Class II | Active |
| True Tulip, True M.I.S. | K220297 | FDA 510(k) | Class II | Active |
| True Tulip, True M.I.S. | K212627 | FDA 510(k) | Class II | Active |
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