Gun, Cement
FDA 510(k) K781955 · Depuy, Inc.
510(k) numberK781955
Submission
- Device name
- Gun, Cement
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- November 21, 1978
- Decision date
- December 4, 1978
- 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 |
| K811317 | Howmedica Femoral Pressuring SealKIH · Traditional | Howmedica Corp. | 05/29/1981SE |
| K801388 | Oh-HarrisKIH · Traditional | Johnson & Johnson Professionals, Inc. | 07/28/1980SE |
| K790275 | Gun, Exeter CementKIH · Traditional | Howmedica Corp. | 02/21/1979SE |
| K780266 | Bone Cement ApplicatorKIH · Traditional | Zimmer, Inc. | 02/28/1978SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K043058 | Pinnacle Constrained Acetabular LinersKWZ · Traditional | 03/14/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | 12/08/2004SE |
| K041085 | LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional | 07/22/2004SE |
| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Gun, Cement cleared by the FDA?
Gun, Cement (K781955) received a 510(k) decision of Substantially Equivalent on December 4, 1978, 13 days after the submission was received.
What is the product code of K781955?
The FDA product code is KIH – Dispenser, Cement, a Class I (low risk) device regulated under 21 CFR 888.4200.