Hook Holler
FDA 510(k) K770759 · Depuy, Inc.
510(k) numberK770759
Submission
- Device name
- Hook Holler
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- April 25, 1977
- Decision date
- April 29, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIK – Hook, Bone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
More from Depuy, Inc.
| 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 Hook Holler cleared by the FDA?
Hook Holler (K770759) received a 510(k) decision of Substantially Equivalent on April 29, 1977, 4 days after the submission was received.
What is the product code of K770759?
The FDA product code is KIK – Hook, Bone, a Class I (low risk) device regulated under 21 CFR 878.4800.