Multitak Splinter 3.0 MM Resorbable Anchor
FDA 510(k) K012465 · Bonutti Research, Inc.
510(k) numberK012465
Submission
- Device name
- Multitak Splinter 3.0 MM Resorbable Anchor
- Applicant
- Bonutti Research, Inc.
Effingham, IL, US - Received
- August 1, 2001
- Decision date
- October 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
More from Stryker Endoscopy
| 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 |
| K010479 | Multitak Conical Tip Bone Soft Tissue Suture AnchorHTY · Traditional | 05/08/2001SE |
Questions and answers
When was Multitak Splinter 3.0 MM Resorbable Anchor cleared by the FDA?
Multitak Splinter 3.0 MM Resorbable Anchor (K012465) received a 510(k) decision of Substantially Equivalent on October 29, 2001, 89 days after the submission was received.
What is the product code of K012465?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.