510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K901814Substantially Equivalent for Some Indications

Mcgrath Orthopaedic Bone Screws

Mcgrath Surgical, Ltd., Po3 5hl England, GB / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K901814 is the FDA 510(k) clearance record for MCGRATH ORTHOPAEDIC BONE SCREWS, a class II device, cleared for Mcgrath Surgical , Ltd. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list one 510(k) clearance for Mcgrath Surgical , Ltd. As of , FDA records show no recalls naming K901814.

Clearance record

Decision date
Received
(120 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Mcgrath Surgical , Ltd. Gunstore Rd., Hilsea, Po3 5hl England, GB
Third party review
No

Clearances, product code HWC

Trailing 12 months
22 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 20261