Cowellmedi

Also known as: Cowellmedi Co., Ltd.

A South Korean biomedical manufacturer in Busan, maker of the INNO implant line and INNO SLA surface, active in bone-regeneration (rhBMP-2) research.

Key facts

Manufacturer	Cowellmedi Co., Ltd.Verified spec[1]
Country	South KoreaVerified spec[1]
Headquarters	Busan, South Korea (Sasang-gu)Verified spec[1]
Founded	Manufacturer documentation not located(Reported as 1994 in trade and distributor material, but not confirmed on a source we could reach.)
manufacturingCountry	South KoreaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Cowellmedi is a Busan biomedical company whose implant range trades under the INNO name, using an SLA (sandblasted, large-grit, acid-etched) surface on grade-4 titanium. Beyond fixtures, the company has a research focus on bone regeneration, including recombinant human BMP-2 work, which distinguishes it from pure fixture manufacturers. We hold the founding year as unverified: the commonly repeated 1994 date is not on any Cowellmedi document we could open, so we prefer to leave it blank rather than restate it.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance13 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

Number	Device	Holder	Date
K242287	SFIT Abutment	Cowellmedi Co., Ltd.	2025-09-16
K241127	INNO SLA Mini Plus® Implant System	Cowellmedi Co., Ltd.	2024-12-27
K231411	INNO SLA Submerged Hybrid Ti-Base System	Cowellmedi Co., Ltd.	2023-12-20
K232546	Meta G UCLA Abutment	Cowellmedi Co., Ltd.	2023-11-21
K231395	INNO SLA Submerged Narrow Implant System	Cowellmedi Co., Ltd.	2023-10-18
K201323	INNO SLA Submerged Implant System	Cowellmedi Co., Ltd.	2022-01-25
K132242	INNO SLA SUBMERGED IMPLANT SYSTEM	Cowellmedi Co., Ltd.	2013-12-06
K100850	COWELL IMPLANT SYSTEM	Cowellmedi Co., Ltd.	2010-12-20
K090054	ATLAS IMPLANT SYSTEM - WIDE PLUS	Cowellmedi Co., Ltd.	2009-07-29
K090049	ATLAS IMPLANT SYSTEM- MINI PLUS	Cowellmedi Co., Ltd.	2009-04-20
K071148	ATLAS IMPLANT SYSTEM	Cowellmedi Co., Ltd.	2008-02-06
K050635	ALLFIM IMPLANT SYSTEMS	Cowellmedi Co., Ltd.	2005-07-28
K041655	BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)	Cowellmedi Co., Ltd.	2004-09-08

Other2 records

Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

Number	Device	Holder	Date
3005115116	—	COWELLMEDI CO., LTD.	—
115 device records	—	Cowellmedi	—

Clearance records for Cowellmedi were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Cowellmedi.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]FDA 510(k) K201323 — INNO SLA Submerged Implant System — U.S. Food & Drug Administration, 2022. Accessed 2026-07-21.
[2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.