Osteo-Cable Sleeve
FDA 510(k) K024022 · Biomet, Inc.
510(k) numberK024022
Submission
- Device name
- Osteo-Cable Sleeve
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- December 5, 2002
- Decision date
- January 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HXN – Applier, Cerclage
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HXN
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|---|---|---|---|
| K841628 | WireHXN · Traditional | Plastafil, Inc. | 07/23/1984SE |
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Questions and answers
When was Osteo-Cable Sleeve cleared by the FDA?
Osteo-Cable Sleeve (K024022) received a 510(k) decision of Substantially Equivalent on January 23, 2003, 49 days after the submission was received.
What is the product code of K024022?
The FDA product code is HXN – Applier, Cerclage, a Class I (low risk) device regulated under 21 CFR 888.4540.