Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)
FDA 510(k) K072961 · Sra Developments, Ltd.
510(k) numberK072961
Submission
- Device name
- Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)
- Applicant
- Sra Developments, Ltd.
Ashburton, Devon, GB - Received
- October 19, 2007
- Decision date
- December 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDX – Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4580
- Specialty
- Orthopedic
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| K051053 | Oscar, Model OE3000DBJDX · Traditional | Orthosonics, Ltd. | 07/21/2005SE |
More from Orthosonics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5LFL · Traditional | 12/15/2022SE |
| K151101 | Lotus Series 4 Ultrasonic Surgical System & AccessoriesLFL · Special | 07/17/2015SE |
| K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery SystemLFL · Traditional | 02/22/2007SE |
| K032424 | LotusLFL · Traditional | 12/16/2003SE |
Questions and answers
When was Lotus Ultrasonic System for Cemented Implant Extraction (Uscix) cleared by the FDA?
Lotus Ultrasonic System for Cemented Implant Extraction (Uscix) (K072961) received a 510(k) decision of Substantially Equivalent on December 19, 2007, 61 days after the submission was received.
What is the product code of K072961?
The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.