Bone Cement Applicator
by Zimmer, Inc.
510(k) K780266
Bone Cement Applicator is a Class I device made by Zimmer, Inc., cleared under FDA 510(k) K780266 on 28 Feb 1978, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780266 | Date28 Feb 1978 | StatusActive |
Official records
- FDA 510(k) database K780266
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KIH
- Device class
- Class I
- Regulation
- 21 CFR Part 888.4200
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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