CarboClear Lumbar Cage System— 510(k) K193378
Substantially EquivalentCarboFix Orthopedics , Ltd.
FDA 510(k) clearance K193378 for CarboClear Lumbar Cage System, Substantially Equivalent on 2020-03-02. Applicant: CarboFix Orthopedics , Ltd.. Device class: 2.
Clearance details
- Applicant
- CarboFix Orthopedics , Ltd.
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Herzeliya, IL
Recent devices under product code MAX
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view all- K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
- K243106 — CarboClear® Hybrid Pedicle Screw System
- K233793 — CarboClear® X Pedicle Screw System
- K240846 — CarboClear® Hybrid Pedicle Screw System +3 more
- K233989 — CarboClear® Posterior Cervical Screw System
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.