Last synced on 25 April 2025 at 11:05 pm

SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043355
510(k) Type
Special
Applicant
SINTEA BIOTECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2004
Days to Decision
11 days
Submission Type
Summary

SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K043355
510(k) Type
Special
Applicant
SINTEA BIOTECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2004
Days to Decision
11 days
Submission Type
Summary