510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K905348Substantially Equivalent

Hansen-Street Type Intramedullary Nail

O'Tec Corp., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905348 is the FDA 510(k) clearance record for HANSEN-STREET TYPE INTRAMEDULLARY NAIL, a class II device, cleared for O'Tec Corp. on under FDA product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component). FDA records list 21 510(k) clearances for O'Tec Corp., from to . As of , FDA records show no recalls naming K905348.

Clearance record

Decision date
Received
(13 days to decision)
Product code
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
O'Tec Corp. 6685 Quince, Memphis TN
Third party review
No

Clearances, product code KTW

Trailing 12 months

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

FDA records show no clearances under product code KTW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KTW, 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