Emerge Medical Solid Bone Screws
FDA 510(k) K122489 · Emerge Medical
510(k) numberK122489
Submission
- Device name
- Emerge Medical Solid Bone Screws
- Applicant
- Emerge Medical
Denver, CO, US - Received
- August 15, 2012
- Decision date
- December 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K141347 | Emerge Medical Im Nail SystemHSB · Traditional | 10/02/2014SE |
| K140675 | Emerge External Fixation SystemKTT · Traditional | 06/10/2014SE |
| K140107 | Emerge Medical Distal Radius SetHRS · Traditional | 03/13/2014SE |
| K140119 | Emerge Medical Periarticular and Locking Large Fragment SystemHRS · Traditional | 03/12/2014SE |
| K140098 | Emerge Medical Small Fragment Locked Plating SystemHRS · Traditional | 03/12/2014SE |
| K133536 | Emerge Medical Bone Plate SystemHRS · Traditional | 02/26/2014SE |
| K133541 | Emerge Medical Small and Large Non-Locking Fragment Plate SystemHRS · Traditional | 01/28/2014SE |
| K133452 | Emerge Medical Small Fragment Locked Plating SystemHRS · Traditional | 01/08/2014SE |
| K131480 | Emerge Medical Locking One-Third Tubular Plate SystemHRS · Traditional | 07/03/2013SE |
| K102343 | Emerge Medical Cannulated Screw Fixation SystemHWC · Traditional | 11/23/2010SE |
Questions and answers
When was Emerge Medical Solid Bone Screws cleared by the FDA?
Emerge Medical Solid Bone Screws (K122489) received a 510(k) decision of Substantially Equivalent on December 10, 2012, 117 days after the submission was received.
What is the product code of K122489?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.