Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires
FDA 510(k) K102743 · Ortho Solutions Limited
510(k) numberK102743
Submission
- Device name
- Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires
- Applicant
- Ortho Solutions Limited
Prior Lake, MN, US - Received
- September 22, 2010
- Decision date
- January 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K143191 | IntelliSense DrillHWE · Traditional | Mcginley Innovations | 02/20/2015SE |
| K063688 | Surgical Irrigation System, Irrigation TubeHWE · Special | The Anspach Effort, Inc. | 01/16/2007SE |
| K050766 | Explant Osteonecrosis Intervention Implant Removal SystemHWE · Traditional | Zimmer Trabecular | 05/26/2005SE |
| K043310 | Synthes (USA) Electric Pen Drive SystemHWE · Traditional | Synthes (Usa) | 01/05/2005SE |
| K022744 | Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional | Medical Device Services | 09/18/2002SE |
| K012694 | Reprocessed Used Disposable Arthroscopic Blades and BursHWE · Traditional | Adven Medical | 02/04/2002SE |
| K012676 | Reprocessed Used, Disposable Blades, Burs, Bits and TapsHWE · Traditional | Adven Medical | 02/04/2002SE |
| K990816 | Avcore SystemHWE · Traditional | Modular Cutting Systems, Inc. | 09/24/1999SE |
| K973736 | Aesculap Hilan Motor SystemHWE · Traditional | Aesculap, Inc. | 12/29/1997SE |
| K973560 | Bone Graft HarvesterHWE · Traditional | Ds Mfg., Inc. | 11/12/1997SE |
More from Ds Mfg., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141784 | Ortho Solutions Ultos Plating SystemHRS · Traditional | 07/23/2014SE |
| K121575 | Oxford Ankle Fusion Nail(Afn) SystemHSB · Traditional | 09/14/2012SE |
| K120360 | Ortho Solutions Trauma Plates for OsteosysnthesisHRS · Traditional | 05/29/2012SE |
| K111678 | Ortho Solutions Extremity Fixation Implants for OsteosysnthesisHRS · Traditional | 02/07/2012SE |
| K110895 | Ortho Solutions Trauma Implants for OsteosynthesisHWC · Traditional | 12/19/2011SE |
Questions and answers
When was Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires cleared by the FDA?
Ortho Solutions - Sterile, Drills, Taps, Guide Pins & Wires (K102743) received a 510(k) decision of Substantially Equivalent on January 20, 2011, 120 days after the submission was received.
What is the product code of K102743?
The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.