Howmedice Bone Plug
510(k) K951860
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK951860 | Date16 May 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LZN
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SN
Overview
AI-generated summary, 25 Sep 2026
The Howmedice Bone Plug is a cement obturator designed for use in surgical procedures. It functions to block the medullary canal during cemented orthopedic applications.
This device is regulated as a Class 2 medical device under FDA 510(k) clearance K951860. It is available in various sizes, including catalog numbers 6215-5-001 and 6215-5-021, and is intended for use within the field of general and plastic surgery.
Other devices from Howmedica Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the primary purpose of the Howmedice Bone Plug?
The Howmedice Bone Plug is designed to function as a cement obturator. Its primary purpose is to block the medullary canal during cemented orthopedic surgical applications.
What sizes are available for this device?
The device is available in various sizes to accommodate different surgical needs, including specific catalog reference numbers 6215-5-001 and 6215-5-021.
Is this device regulated for use?
Yes, the Howmedice Bone Plug is regulated as a Class 2 medical device. It received FDA 510(k) clearance under the number K951860, which indicates it has been found substantially equivalent to other legally marketed devices for its intended use.