Dispenser, Cement
Cement Dispenser is a surgical instrument used in orthopedic procedures to prepare and deliver bone cement (polymethylmethacrylate) into the implant site or bone cavity, providing controlled placement of the cement to secure orthopedic implants or fill bone defects. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIH, regulated under 21 CFR 888.4200, within the Orthopedic medical specialty.
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Basic Information
- Product Code
- KIH
- Device Class
- FDA class 1
- Regulation Number
- 888.4200
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042591 | SMARTMIX PRE-FILLED MIXING SYSTEM | Oct 22, 2004 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K943906 | P.F.C. CEMENT PRESSURIZING SYSTEM | Dec 21, 1994 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K897134 | CMW CEMENT PRESSURISATION SYSTEM | Mar 02, 1990 | Substantially Equivalent | Dentsply Intl. |
| K851881 | ORTHOPEADIC CEMENT DELIVERY SYSTEM | Jun 13, 1985 | Substantially Equivalent | Dentsply Intl. |
| K840046 | PRESSURIZING/SCAVENGING ACRYLIC CEMENT | Feb 09, 1984 | Substantially Equivalent | Precision Medical Devices, Inc. |
| K833675 | BRIGHAM TIBIAL CEMENT PRESSURIZER | Dec 12, 1983 | Substantially Equivalent | Howmedica Corp. |
| K811317 | HOWMEDICA FEMORAL PRESSURING SEAL | May 29, 1981 | Substantially Equivalent | Howmedica Corp. |
| K801388 | OH-HARRIS | Jul 28, 1980 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K790275 | GUN, EXETER CEMENT | Feb 21, 1979 | Substantially Equivalent | Howmedica Corp. |
| K781955 | GUN, CEMENT | Dec 04, 1978 | Substantially Equivalent | Depuy, Inc. |
| K780266 | BONE CEMENT APPLICATOR | Feb 28, 1978 | Substantially Equivalent | Zimmer, Inc. |
FEI Numbers
This FDA classification entry is associated with 103 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 103 registration numbers. Click on an entry to view related FDA registrations.