Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012103978

FEI Number

3012103978

Entity Name

Stryker Endoscopy

City/State/Country

Greenwood Village, CO, US

Establishment Address

5670 Greenwood Plaza Blvd, Suite 125, Greenwood Village, CO 80111, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170098

PMA Number

N/A

All Registered Proprietary Names

ICONIX SPEED SharpShooter Handle ICONIX SPEED ICONIX Self Punching Anchor Crosscut WIRE CUTTER Big Dog Suture Center ProCinch ProCinch Standard Tension Adjustable Loop ProCinch Reverse Tension Adjustable Loop ICONIX TT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-09-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-11-21
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1995-05-19
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2015-08-06
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-08-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012103978. Last updated year: 2026. Please use registration number 3012103978 when referencing this establishment in official correspondence.