Global Total Shoulder, Uncement Humeral Hemi-Shoul
FDA 510(k) K911686 · Depuy, Inc.
510(k) numberK911686
Submission
- Device name
- Global Total Shoulder, Uncement Humeral Hemi-Shoul
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- April 16, 1991
- Decision date
- July 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3690
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
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| K191433 | AGILON® XO Shoulder Replacement SystemHSD · Traditional | Implantcast GmbH | 11/12/2020SE |
| K193122 | Biocore9 Humeral Resurfacing SystemHSD · Traditional | Biocore9, LLC | 05/15/2020SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | Arthrosurface, Inc. | 04/18/2018SE |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional | Arthrex, Inc. | 11/21/2016SE |
| K161620 | Anatomical Shoulder Domelock Dome centricHSD · Traditional | Zimmer GmbH | 11/01/2016SE |
| K151527 | Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional | Arthrex, Inc. | 04/19/2016SE |
| K142942 | HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special | Arthrosurface, Inc. | 12/19/2014SE |
| K131298 | Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional | Exactech, Inc. | 11/26/2013SE |
More from Exactech, 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 Global Total Shoulder, Uncement Humeral Hemi-Shoul cleared by the FDA?
Global Total Shoulder, Uncement Humeral Hemi-Shoul (K911686) received a 510(k) decision of Substantially Equivalent on July 15, 1991, 90 days after the submission was received.
What is the product code of K911686?
The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.