Bone Screws
FDA 510(k) K923841 · Instrument Makar, Inc.
510(k) numberK923841
Submission
- Device name
- Bone Screws
- Applicant
- Instrument Makar, Inc.
Lansing, MI, US - Received
- July 31, 1992
- Decision date
- October 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| 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 |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K930980 | Instrument Makar Perfix Interference Bone ScrewHWC · Traditional | 02/10/1994SN |
Questions and answers
When was Bone Screws cleared by the FDA?
Bone Screws (K923841) received a 510(k) decision of Substantially Equivalent on October 27, 1993, 453 days after the submission was received.
What is the product code of K923841?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.