510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043355Substantially Equivalent

Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model Pls.01.t5.x

Sintea Biotech, Inc., Miami Beach FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043355 is the FDA 510(k) clearance record for SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X, a class II device, cleared for Sintea Biotech, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 10 510(k) clearances for Sintea Biotech, Inc., from to . As of , FDA records show no recalls naming K043355.

Clearance record

Decision date
Received
(11 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Sintea Biotech, Inc. 407 Lincoln Rd., Miami Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWP

Trailing 12 months

FDA records hold no clearances under product code KWP in the trailing twelve months.

FDA records show no clearances under product code KWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260