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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-98/
- Published: 2019-07-07T12:00:00.000Z
- Updated: 2026-09-15T01:35:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5130429

**DEVICES**

FDA has cleared an **Integra LifeSciences Holdings** 510(k) for its Integra Expandable Interbody System for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease. The device is intended for use with autogenous bone graft and supplemental fixation, and can be used in either posterior or transforaminal lumbar interbody fusion procedures.

FDA has cleared a **Medicrea Group** 510(k) for its UNiD, a patient-specific spinal osteosynthesis rod. The device features a “a user-friendly software tool to help surgeons preoperatively plan their surgery and order customized, industrially-produced rods to fit the specific spinal alignment needed for each individual patient,” the company says. “UNiD eliminates the need to manually contour a rod during surgery, providing surgeons with a precisely aligned rod prior to surgery and reducing the amount of time patients spend in the operating room, which directly impacts infection rate and quality of recovery.”

FDA has cleared a **Titan Spine** 510(k) for its Endoskeleton line of interbody fusion implants featuring its next-generation nanoLOCK surface technology. The nanoLOCK allows an “increased amount of nano-scaled textures to up-regulate a statistically significant greater amount of the osteogenic and angiogenic growth factors that are critical for bone growth and fusion” when compared to currently used devices, the company says.

**West Pharmaceutical Services** has won FDA clearance for its NovaGuard SA safety system that prevents needle-sticks by providing a mechanism that can be activated to cover the needle immediately after injection. According to the company, the device has an indicator if the shield has been damaged and it will then become non-functional if that happens to make sure it is disposed of properly. The NovaGuard system is compatible with pre-filled ISO standard glass syringes.

**Zimmer Spine** has received FDA 510(k) clearance for its Optio-C Anterior Cervical Plate for use with structural allograft/autograft as a stand-alone cervical system for cervical fusion procedures. The company says the device offers secure fixation with no profile, and is secured by an anti-migration system, which is “designed to maximize fusion with a unique load-sharing interface and multiple implant footprints.

**HUMAN DRUGS**

**Qualitest,** a subsidiary of **Endo International** has received final FDA approval for its ANDA for valganciclovir tablets USP, 450 mg, a generic version of Hoffmann-La Roche’s Valcyte, an antiviral medicine indicated for treating cytomegalovirus (CMV) retinitis in patients with AIDS for preventing CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk.

**Janssen Pharmaceuticals** has received FDA approval of its supplemental NDAs for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The company says it is the first FDA-approved once-monthly medication to treat schizoaffective disorder as monotherapy.

FDA has approved a **Par Pharmaceutical** NDA for Vasostrict (vasopressin injection) 20 units/mL, indicated for increasing blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.