510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K895802Substantially Equivalent for Some Indications

Non Constrained Total Shoulder System

Orthopaedic Medical Group, Inc., South San Francisco CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K895802 is the FDA 510(k) clearance record for NON CONSTRAINED TOTAL SHOULDER SYSTEM, a class II device, cleared for Orthopaedic Medical Group, Inc. on under FDA product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented). FDA records list one 510(k) clearance for Orthopaedic Medical Group, Inc. As of , FDA records show no recalls naming K895802.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3650
Device class
Class II
Review panel
Orthopedic
Applicant
Orthopaedic Medical Group, Inc. 2400 Westborough Blvd., South San Francisco CA
Third party review
No

Clearances, product code KWT

Trailing 12 months
2 clearances under product code KWT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260