510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K875050Substantially Equivalent

Orthomet Bone Screws

Orthomet, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875050 is the FDA 510(k) clearance record for ORTHOMET BONE SCREWS, a class II device, cleared for Orthomet, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 60 510(k) clearances for Orthomet, Inc., from to . As of , FDA records show no recalls naming K875050.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Orthomet, Inc. 6301 Cecilia Cir., Minneapolis MN
Third party review
No

Clearances, product code HWC

Trailing 12 months
23 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 20262