SurgTech Thoracolumbosacral (TLS) Posterior Fixation System— 510(k) K163363
Substantially EquivalentSurgtech, Inc.
FDA 510(k) clearance K163363 for SurgTech Thoracolumbosacral (TLS) Posterior Fixation System, Substantially Equivalent on 2017-04-05. Applicant: Surgtech, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgtech, Inc.
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
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More clearances from Surgtech, Inc.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.