Osteoplast, Model POP200
by Interpore Cross Intl. 510(k)
Active
510(k) K991854
Overview
The Osteoplast, Model POP200 is an orthopedic device classified under product code MQV. It is designed for use in orthopedic procedures, though the specific indications are not detailed in the provided data.
The device received FDA 510(k) clearance on August 26, 1999, with a K number of K991854, and was determined to be substantially equivalent. It is manufactured by Interpore Cross International and is supplied in various sizes as indicated by the model number.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991854 | Date26 Aug 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MQV
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Interpore Cross Intl.
Questions
What is the Osteoplast POP200 used for?
The Osteoplast POP200 is an orthopedic device designed for use in orthopedic procedures, though the specific indications are not detailed in the provided data.
How is the Osteoplast POP200 supplied?
The device is supplied in various sizes as indicated by the model number, manufactured by Interpore Cross International.
What is the regulatory status of the Osteoplast POP200?
The Osteoplast POP200 received FDA 510(k) clearance on August 26, 1999, with K number K991854, and was determined to be substantially equivalent.
Is the Osteoplast POP200 a single-use or reusable device?
The provided data does not specify whether the Osteoplast POP200 is designed for single-use or reuse.