INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE— 510(k) K131540
Substantially EquivalentVertebral Technologies, Inc.
FDA 510(k) clearance K131540 for INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE, Substantially Equivalent on 2013-09-03. Applicant: Vertebral Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Vertebral Technologies, Inc.
- Product code
- 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
- Minneapolis, MN, US
Recent devices under product code MAX
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- K102277 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
- K093675 — INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
- K091988 — MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
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.