Cross Medical Bone Plate System/ CM Bone Plate System/Cross Ti Bone Plate System
FDA 510(k) K961320 · Buckman Co., Inc.
510(k) numberK961320
Submission
- Device name
- Cross Medical Bone Plate System/ CM Bone Plate System/Cross Ti Bone Plate System
- Applicant
- Buckman Co., Inc.
Concord, CA, US - Received
- April 5, 1996
- Decision date
- June 25, 1998
- 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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Questions and answers
When was Cross Medical Bone Plate System/ CM Bone Plate System/Cross Ti Bone Plate System cleared by the FDA?
Cross Medical Bone Plate System/ CM Bone Plate System/Cross Ti Bone Plate System (K961320) received a 510(k) decision of Substantially Equivalent on June 25, 1998, 811 days after the submission was received.
What is the product code of K961320?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.