The Corifix Ligament Anchor
FDA 510(k) K973005 · Corin USA
510(k) numberK973005
Submission
- Device name
- The Corifix Ligament Anchor
- Applicant
- Corin USA
Tampa, FL, US - Received
- August 13, 1997
- Decision date
- November 10, 1997
- 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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| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
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| 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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| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA)LZO · Traditional | 07/22/2019SE |
| K183038 | Corin Optimized Positioning System (OPS) PlanLLZ · Traditional | 11/26/2018SE |
| K181061 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 09/07/2018SE |
| K152893 | Corin Optimized Positioning System (OPS)LZO · Traditional | 06/03/2016SE |
Questions and answers
When was The Corifix Ligament Anchor cleared by the FDA?
The Corifix Ligament Anchor (K973005) received a 510(k) decision of Substantially Equivalent on November 10, 1997, 89 days after the submission was received.
What is the product code of K973005?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.