Howmedica Femoral Pressuring Seal
FDA 510(k) K811317 · Howmedica Corp.
510(k) numberK811317
Submission
- Device name
- Howmedica Femoral Pressuring Seal
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- May 12, 1981
- Decision date
- May 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIH – Dispenser, Cement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4200
- Specialty
- Orthopedic
Other 510(k)s with product code KIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042591 | Smartmix Pre-Filled Mixing SystemKIH · Special | DePuy Orthopaedics, Inc. | 10/22/2004SE |
| K943906 | P.F.C. Cement Pressurizing SystemKIH · Traditional | Johnson & Johnson Professionals, Inc. | 12/21/1994SE |
| K897134 | CMW Cement Pressurisation SystemKIH · Traditional | Dentsply Intl. | 03/02/1990SE |
| K851881 | Orthopeadic Cement Delivery SystemKIH · Traditional | Dentsply Intl. | 06/13/1985SE |
| K840046 | Pressurizing/Scavenging Acrylic CementKIH · Traditional | Precision Medical Devices, Inc. | 02/09/1984SE |
| K833675 | Brigham Tibial Cement PressurizerKIH · Traditional | Howmedica Corp. | 12/12/1983SE |
| K801388 | Oh-HarrisKIH · Traditional | Johnson & Johnson Professionals, Inc. | 07/28/1980SE |
| K790275 | Gun, Exeter CementKIH · Traditional | Howmedica Corp. | 02/21/1979SE |
| K781955 | Gun, CementKIH · Traditional | Depuy, Inc. | 12/04/1978SE |
| K780266 | Bone Cement ApplicatorKIH · Traditional | Zimmer, Inc. | 02/28/1978SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984251 | Xia Spine SystemKWQ · Traditional | 02/24/1999SE |
| K984202 | Howmedica Humeral Intercalary SystemHSD · Traditional | 02/05/1999SE |
| K984305 | Zeta Multizone Locking Nail SystemHSB · Traditional | 02/01/1999SE |
| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Howmedica Femoral Pressuring Seal cleared by the FDA?
Howmedica Femoral Pressuring Seal (K811317) received a 510(k) decision of Substantially Equivalent on May 29, 1981, 17 days after the submission was received.
What is the product code of K811317?
The FDA product code is KIH – Dispenser, Cement, a Class I (low risk) device regulated under 21 CFR 888.4200.