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ULC SPINAL PEDICLE SCREW SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083077
510(k) Type
Traditional
Applicant
OTIS BIOTECH CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/26/2009
Days to Decision
375 days
Submission Type
Summary

ULC SPINAL PEDICLE SCREW SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083077
510(k) Type
Traditional
Applicant
OTIS BIOTECH CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/26/2009
Days to Decision
375 days
Submission Type
Summary