Hiploc Compression Hip Screw
FDA 510(k) K080685 · Biomet Manufacturing, Inc.
510(k) numberK080685
Submission
- Device name
- Hiploc Compression Hip Screw
- Applicant
- Biomet Manufacturing, Inc.
Warsaw, IN, US - Received
- March 11, 2008
- Decision date
- August 15, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDO – Device, Fixation, Proximal Femoral, Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDO
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|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | OsteoCentric Technologies | 04/18/2023SE |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…JDO · Traditional | Smith & Nephew, Inc. | 09/29/2022SE |
| K210247 | OsteoCentric Integrated Hip Fastener SystemJDO · Traditional | Osteocentric Technologies D.B.A. Osteocentric… | 04/30/2021SE |
| K193029 | Conquest FNJDO · Traditional | Smith & Nephew, Inc. | 02/28/2020SE |
| K173826 | THP Hip Fracture Plating SystemJDO · Traditional | Biomet, Inc. | 02/07/2018SE |
| K172785 | Conquest FNJDO · Special | Smith & Nephew | 12/22/2017SE |
| K152686 | Conquest FNJDO · Traditional | Smith & Nephew | 03/17/2016SE |
| K140018 | TSP Hip Fracture Plating SystemJDO · Traditional | Biomet, Inc. | 04/04/2014SE |
| K080434 | Intertan CHS Locking Plate System Prox Fem Plates/ScrewJDO · Traditional | Smith & Nephew, Inc. | 04/10/2008SE |
| K983814 | Gotfried Percutaneous Compression Plating SystemJDO · Traditional | Efratgo, Ltd. HI Tech Bio-Surgical | 01/14/1999SE |
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| K202232 | Comprehensive Vault Reconstruction SystemPHX · Traditional | 02/19/2021SE |
| K193038 | Comprehensive Shoulder SystemMBF · Traditional | 10/28/2020SE |
| K182516 | Comprehensive Nano Stemless ShoulderPKC · Traditional | 04/22/2019SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | 09/24/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | 02/08/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | 01/03/2018SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
Questions and answers
When was Hiploc Compression Hip Screw cleared by the FDA?
Hiploc Compression Hip Screw (K080685) received a 510(k) decision of Substantially Equivalent on August 15, 2008, 157 days after the submission was received.
What is the product code of K080685?
The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.