Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027262786

FEI Number

3027262786

Entity Name

SOLENDOS., INC.

City/State/Country

GURO-GU Seoul, KR

Establishment Address

#503 5F, E&C VENTURE DREAM TOWER3 38-21 DIGITAL-RO 31 GIL,, GURO-GU, SEOUL, GURO-GU Seoul 08376, KR

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Solendos., INC. (Owner Number: 10089428)

Owner / Operator Contact Address

#503 5F, E&C VENTURE DREAM TOWER3 38-21 DIGITAL-RO 31 GIL,, GURO-GU, SEOUL, #505 5F, E&C VENTURE DREAM TOWER3 38-21 DIGITAL-RO 31 GIL,, GURO-GU, SEOUL, GURO-GU, KR-11 08376, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

[Target] TIK0001L Indian Knife(Long) [Target] TML0001 Mallet [Target] TCH0001L Straight Chisel 5mm [Target] TCH0002L Hockey Chisel Left 5mm [Target] TCH0004L Pedicle Chisel 4mm [Target] TCH0003L Hockey Chisel Right 5mm [Target] TMP0002 Micro Pituitary 2mm Up [Target] TMP0001 Micro Pituitary 2mm Straight [Target] TRP0002 Rotational Punch Head 3mm [Target] TFP0001 Foraminal Punch 2mm [Target] TFP0002 Foraminal Punch 3mm [Target] TRP0001 Rotational Punch Head 2mm [Target] TFR0001 Freer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2023-12-07
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2024-12-03
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2023-12-07
HTX	Rongeur	Orthopedic	Class 1	888.4540	2023-12-07
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-12-07
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-12-07

Official Correspondent

Soochul Kim

US Agent Details

Cori Ragan Business: Cori Ragan Email: Cori.Ragan@fortrea.com Phone: (612) 4834578

Related Public Records

Same Entity

Solendos., INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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8010155	A.HANDTE MEDIZINTECHNIK GMBH & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
3015259876	B-ONE ORTHO, CORP.	Cedar Knolls, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027262786. Last updated year: 2026. Please use registration number 3027262786 when referencing this establishment in official correspondence.