Instrument Makar Perfix Interference Bone Screw
FDA 510(k) K930980 · Instrument Makar, Inc.
510(k) numberK930980
Submission
- Device name
- Instrument Makar Perfix Interference Bone Screw
- Applicant
- Instrument Makar, Inc.
Washington, DC, US - Received
- February 25, 1993
- Decision date
- February 10, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
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| K002600 | Litwin Cruicate AnchorMBI · Traditional | 11/15/2000SE |
| K980999 | ST Leger Cemented Semi-Constrained Total Knee ImplantJWH · Traditional | 11/06/1998SE |
| K963396 | Biosphere Suture AnchorMAI · Traditional | 05/06/1997SE |
| K964364 | Disposable ApronLYU · Traditional | 02/25/1997SE |
| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | 11/19/1996SE |
| K960555 | Bioasbsorbable Mini-Screw Suture AnchorMAI · Traditional | 07/09/1996SE |
| K943249 | Bioabsorbable Interference ScrewMAI · Traditional | 07/31/1995SE |
| K944062 | Laprascopic GrasperGCS · Traditional | 02/23/1995SE |
| K942828 | Makar Full and Half Face ShieldLYU · Traditional | 02/23/1995SE |
| K923841 | Bone ScrewsHWC · Traditional | 10/27/1993SE |
Questions and answers
When was Instrument Makar Perfix Interference Bone Screw cleared by the FDA?
Instrument Makar Perfix Interference Bone Screw (K930980) received a 510(k) decision of Substantially Equivalent for Some Indications on February 10, 1994, 350 days after the submission was received.
What is the product code of K930980?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.