Multitak Conical Tip Bone Soft Tissue Suture Anchor
FDA 510(k) K010479 · Bonutti Research, Inc.
510(k) numberK010479
Submission
- Device name
- Multitak Conical Tip Bone Soft Tissue Suture Anchor
- Applicant
- Bonutti Research, Inc.
Effingham, IL, US - Received
- February 20, 2001
- Decision date
- May 8, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K161628 | JAS Pulse(TM) Ultrasonic TherapyIMI · Abbreviated | 11/10/2016SE |
| K093078 | Unity Ultrasonic System with Plla AnchorsHWC · Special | 06/23/2010SE |
| K090175 | Unity Beta Plla SystemHWC · Traditional | 09/10/2009SE |
| K082906 | Unity Beta Anchor SystemHWC · Special | 10/30/2008SE |
| K062820 | Unity Alpha SystemHWC · Traditional | 03/15/2007SE |
| K060283 | Transet SystemHTY · Special | 02/22/2006SE |
| K052799 | Multitak 6.0 MM Absorbable Anchor SystemMAI · Traditional | 12/16/2005SE |
| K033717 | Transet Fracture Fixation SystemHTY · Traditional | 02/25/2004SE |
| K013177 | Multitak Suture Snap SystemGAM · Traditional | 12/19/2001SE |
| K012465 | Multitak Splinter 3.0 MM Resorbable AnchorMAI · Traditional | 10/29/2001SE |
Questions and answers
When was Multitak Conical Tip Bone Soft Tissue Suture Anchor cleared by the FDA?
Multitak Conical Tip Bone Soft Tissue Suture Anchor (K010479) received a 510(k) decision of Substantially Equivalent on May 8, 2001, 77 days after the submission was received.
What is the product code of K010479?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.