510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934860Substantially Equivalent

Ti-Frame

Johnson & Johnson Professionals, Inc., Randolph MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934860 is the FDA 510(k) clearance record for TI-FRAME, a class II device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K934860.

Clearance record

Decision date
Received
(234 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Johnson & Johnson Professionals, Inc. 41 Pacella Park Dr., Randolph MA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260