Surgicraft Screw Fixation System
FDA 510(k) K080447 · Surgicraft , Ltd.
510(k) numberK080447
Submission
- Device name
- Surgicraft Screw Fixation System
- Applicant
- Surgicraft , Ltd.
Douglassville, PA, US - Received
- February 19, 2008
- Decision date
- June 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K091207 | Surgicraft Lockdown Acromioclavicular (Ac) DeviceHTN · Traditional | 02/15/2011SE |
| K072370 | Surgicraft Surgical Mesh SystemFTL · Traditional | 07/24/2008SE |
| K073109 | Stalif TT Intervertebral Body Fusion SystemOVD · Abbreviated | 06/04/2008SE |
| K072415 | Stalif (TM) COVE · Abbreviated | 01/25/2008SE |
| K051027 | Stalif TTMQP · Traditional | 06/29/2005SE |
| K041617 | Stalif TTMQP · Traditional | 09/08/2004SE |
| K991662 | Titanium Hartshill SystemKWP · Traditional | 11/08/1999SE |
| K982719 | The Bone TieHTY · Traditional | 09/25/1998SE |
| K965221 | Ransford Cervical Fixation SystemKWP · Traditional | 08/07/1997SE |
Questions and answers
When was Surgicraft Screw Fixation System cleared by the FDA?
Surgicraft Screw Fixation System (K080447) received a 510(k) decision of Substantially Equivalent on June 13, 2008, 115 days after the submission was received.
What is the product code of K080447?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.