Omniplastic Bone Cement
by L.D. Caulk Co. PMA
Active
PMA N17113
Overview
Omniplastic Bone Cement is a medical device classified as bone cement, used in orthopedic applications. It is a polymer-based material designed to anchor orthopedic implants to bone tissue.
The device is supplied as a sterile, single-use product and is not intended for MRI environments. It is authorized under FDA PMA number N17113 with product code LOD and is manufactured by L.D. Caulk Co. in Milford, DE.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberN17113 | Date16 Sep 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- BONE CEMENT
- PMA Number
- FDA Product Code
- LOD
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3027
- Advisory Committee
- Orthopedic
- FDA Decision
- APRL
Other devices from L.D. Caulk Co.
Questions
What is the primary purpose of Omniplastic Bone Cement?
Omniplastic Bone Cement is a polymer-based medical device designed to anchor orthopedic implants to bone tissue in orthopedic applications.
Is the Omniplastic Bone Cement reusable or single-use?
The device is supplied as a sterile, single-use product and is not intended for reuse in any clinical setting.
What are the storage requirements for Omniplastic Bone Cement?
The device data does not specify storage requirements, so clinicians should refer to the manufacturer's instructions for proper storage conditions.
Is Omniplastic Bone Cement suitable for use in MRI environments?
No, the device is not intended for use in MRI environments as specified in the product description.
What is the regulatory authorization for Omniplastic Bone Cement?
The device is authorized under FDA PMA number N17113 with product code LOD, indicating it has received Premarket Approval from the FDA.