FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KLS Martin Oral-Max Implants MR Conditional (bundled)
K Number: K241314
·
Decision Aug 16, 2024
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
58
Review Days
98
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Basic Information
- Device Name
- KLS Martin Oral-Max Implants MR Conditional (bundled)
- K Number
- K241314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KLS-Martin L.P.
- Date Received
- May 10, 2024
- Decision Date
- August 16, 2024
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by KLS-Martin L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K253660 | KLS Martin Pure Pectus System | Feb 20, 2026 | Substantially Equivalent |
| K250988 | KLS Martin Pure Pectus System | Dec 11, 2025 | Substantially Equivalent |
| K250865 | KLS Martin IPS Forearm System | Nov 14, 2025 | Substantially Equivalent |
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| K233721 | KLS Martin Drill-Free MMF Screw | Sep 17, 2024 | Substantially Equivalent |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | Jul 12, 2024 | Substantially Equivalent |
| K230211 | CranioXpand | Nov 21, 2023 | Substantially Equivalent |
| K222624 | KLS Martin LINOS Wrist System | May 25, 2023 | Substantially Equivalent |
| K222397 | KLS Martin Level One Rib Fixation System | Mar 29, 2023 | Substantially Equivalent |
| K210731 | KLS Martin Individual Patient Solutions | Jul 18, 2022 | Substantially Equivalent |