Mitek BTB Absorbable (Pla) Cross Pin
FDA 510(k) K974341 · Mitek Products
510(k) numberK974341
Submission
- Device name
- Mitek BTB Absorbable (Pla) Cross Pin
- Applicant
- Mitek Products
Westwood, MA, US - Received
- November 18, 1997
- Decision date
- April 16, 1998
- 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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| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
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More from OSSIO , Ltd.
| 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 |
| K003076 | Mitek CufftackMAI · Special | 10/27/2000SE |
| 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 |
Questions and answers
When was Mitek BTB Absorbable (Pla) Cross Pin cleared by the FDA?
Mitek BTB Absorbable (Pla) Cross Pin (K974341) received a 510(k) decision of Substantially Equivalent on April 16, 1998, 149 days after the submission was received.
What is the product code of K974341?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.