510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130635Substantially Equivalent

Seviin Surface Replacement Shoulder

Ingen Orthopedics, LLC, Cranbury NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130635 is the FDA 510(k) clearance record for SEVIIN SURFACE REPLACEMENT SHOULDER, a class II device, cleared for Ingen Orthopedics, LLC on under FDA product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented). FDA records list 3 510(k) clearances for Ingen Orthopedics, LLC, from to . As of , FDA records show no recalls naming K130635.

Clearance record

Decision date
Received
(168 days to decision)
Product code
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Regulation
21 CFR 888.3690
Device class
Class II
Review panel
Orthopedic
Applicant
Ingen Orthopedics, LLC 2650 Us Hwy. 130, Cranbury NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSD

Trailing 12 months

FDA records hold no clearances under product code HSD in the trailing twelve months.

FDA records show no clearances under product code HSD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HSD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260