Mitek Cufftack
FDA 510(k) K003076 · Mitek Products
510(k) numberK003076
Submission
- Device name
- Mitek Cufftack
- Applicant
- Mitek Products
Norwood, MA, US - Received
- October 3, 2000
- Decision date
- October 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K013572 | Mitek Biocryl Interference ScrewsHWC · Special | 03/14/2002SE |
| K013781 | Rididfix 2.7MM BTB Cross Pin KitHTY · Traditional | 02/06/2002SE |
| K002639 | Bioknotless AnchorGAM · Traditional | 05/11/2001SE |
| K010633 | Rigidfix Soft Tissue Acl Crosspin SystemHWC · Traditional | 05/09/2001SE |
| K002406 | Mitek 2GII Meniscal Repair SystemMAI · Traditional | 02/15/2001SE |
| K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemGEI · Special | 08/31/2000SE |
| K002402 | Vapr TC Electrode for Use with Vapr II Electrosurgical SystemHRX · Special | 08/31/2000SE |
| K000936 | Vapr 2.3MM Wedge Electrode for Use with Vapr SystemGEI · Special | 04/19/2000SE |
| K993575 | Resolve QuickanchorDZL · Traditional | 12/29/1999SE |
| K993327 | Talon Anchor Snap-PakDZL · Traditional | 12/16/1999SE |
Questions and answers
When was Mitek Cufftack cleared by the FDA?
Mitek Cufftack (K003076) received a 510(k) decision of Substantially Equivalent on October 27, 2000, 24 days after the submission was received.
What is the product code of K003076?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.