Skip to product information
1 of 1

FDA 510(k) K203714, NuVasive Thoracolumbar Interbody Systems (Multiple Models), by Nu Vasive, Incorporated

FDA 510(k) K203714, NuVasive Thoracolumbar Interbody Systems (Multiple Models), by Nu Vasive, Incorporated

Regular price $1,976.54 USD
Regular price Sale price $1,976.54 USD
Sale Sold out

FDA 510(k) records for NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty (K203714), submitted by Nu Vasive, Incorporated.

  • 510(k) Number: K203714
  • Applicant: Nu Vasive, Incorporated
  • Decision Date: 12/23/2021
  • Decision: Substantially Equivalent (SESE)
  • Product Code: MAX MAX
  • Review Panel: Orthopedic

 

  • Total PDF Pages: 3045
  • Fully Redacted Pages: 752
  • Usable Pages: 2293

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

View full details