Simplex P Bone Cement

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Surgical Simplex(R) P Bone Cement

Trade Name

Surgical Simpled P Bone Cement

Generic Name

BONE CEMENT

PMA Number

N17003 ↗

FDA Product Code

LOD

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

APRL

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See all devices from Howmedica Corp. →

• What is the Surgical Simplex P Bone Cement used for?

  Surgical Simplex P Bone Cement is a radiographic orthopedic bone cement designed to stabilize bone fragments, particularly in joint replacements such as hip and knee arthroplasties. It serves as both an adhesive and filler material in orthopedic surgical procedures.

• Is the Surgical Simplex P Bone Cement supplied as a single-use product?

  Yes, the Surgical Simplex P Bone Cement is supplied as a sterile, single-use product intended for use in sterile operating room environments. It must be handled according to manufacturer guidelines to ensure proper application and safety.

• What regulatory approval does the Surgical Simplex P Bone Cement have?

  The Surgical Simplex P Bone Cement is regulated under FDA Premarket Approval (PMA) with the PMA number N17003. It is classified under product code LOD and has device class 2 status.

• In what forms is the Surgical Simplex P Bone Cement available?

  The Surgical Simplex P Bone Cement is provided in various sizes and formulations, as indicated by the numerous FEI numbers associated with the product. These different formulations allow for customization based on specific surgical requirements.