Symphony Graft Delivery System (GDS)
FDA 510(k) K012738 · Depuyacromed
510(k) numberK012738
Submission
- Device name
- Symphony Graft Delivery System (GDS)
- Applicant
- Depuyacromed
Raynham, MA, US - Received
- August 16, 2001
- Decision date
- November 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
| K964073 | Bme Bone Drill BitsGEY · Traditional | Biomedical Ent., Inc. | 11/14/1996SE |
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| K030249 | Surgical Titanium Mesh SystemMQP · Special | 02/14/2003SE |
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| K023835 | Devex Mesh SystemMQP · Special | 01/29/2003SE |
| K024348 | Monarch Spine SystemMNH · Special | 01/28/2003SE |
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| K021039 | Bowti Anterior Buttress Staple SystemKWQ · Traditional | 12/11/2002SE |
Questions and answers
When was Symphony Graft Delivery System (GDS) cleared by the FDA?
Symphony Graft Delivery System (GDS) (K012738) received a 510(k) decision of Substantially Equivalent on November 14, 2001, 90 days after the submission was received.
What is the product code of K012738?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.