510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163489Substantially Equivalent

OrthoSolutions 'System26' Bone Screws

Ortho Solutions Inc, Maldon, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163489 is the FDA 510(k) clearance record for OrthoSolutions 'System26' Bone Screws, a class II device, cleared for Ortho Solutions UK Limited on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 11 510(k) clearances for Ortho Solutions Inc, from to . As of , FDA records show one recall naming K163489.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Ortho Solutions UK Limited West Station Business Park, Spital Rd., Maldon, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HWC

Trailing 12 months
21 clearances under product code HWC in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20260