Periosteal Elevator
FDA 510(k) K771747 · Depuy, Inc.
510(k) numberK771747
Submission
- Device name
- Periosteal Elevator
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- September 15, 1977
- Decision date
- September 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EMJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870589 | Elevator, Root, Single-EndedEMJ · Traditional | Military Engineering, Inc. | 04/03/1987SE |
| K851717 | 880/1 to 890/4 Various Types of Perioteal ElevatorEMJ · Traditional | Artiberia | 06/14/1985SE |
| K851713 | 680/1 to 785/2 Various Types & Sizes of Root ElevaEMJ · Traditional | Artiberia | 06/11/1985SE |
| K850906 | Tactile Plus Dental ElevatorsEMJ · Traditional | Ipco Corp. | 04/12/1985SE |
| K821788 | Beach Deriosteal Elevator, #2 StraightEMJ · Traditional | Pacific Dental Corp. | 07/06/1982SE |
More from Pacific Dental Corp.
| 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 Periosteal Elevator cleared by the FDA?
Periosteal Elevator (K771747) received a 510(k) decision of Substantially Equivalent on September 28, 1977, 13 days after the submission was received.
What is the product code of K771747?
The FDA product code is EMJ – Elevator, Surgical, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.