Bioabsorbable Interference Screw
FDA 510(k) K943249 · Instrument Makar, Inc.
510(k) numberK943249
Submission
- Device name
- Bioabsorbable Interference Screw
- Applicant
- Instrument Makar, Inc.
Washington, DC, US - Received
- July 6, 1994
- Decision date
- July 31, 1995
- 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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| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
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| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
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| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
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| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | 11/19/1996SE |
| K960555 | Bioasbsorbable Mini-Screw Suture AnchorMAI · Traditional | 07/09/1996SE |
| K944062 | Laprascopic GrasperGCS · Traditional | 02/23/1995SE |
| K942828 | Makar Full and Half Face ShieldLYU · Traditional | 02/23/1995SE |
| K930980 | Instrument Makar Perfix Interference Bone ScrewHWC · Traditional | 02/10/1994SN |
| K923841 | Bone ScrewsHWC · Traditional | 10/27/1993SE |
Questions and answers
When was Bioabsorbable Interference Screw cleared by the FDA?
Bioabsorbable Interference Screw (K943249) received a 510(k) decision of Substantially Equivalent on July 31, 1995, 390 days after the submission was received.
What is the product code of K943249?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.