Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022472578

FEI Number

3022472578

Entity Name

SURGICAL FUSION INC.

City/State/Country

Englewood Cliffs, NJ, US

Establishment Address

930 Sylvan Ave, Suite 125, Englewood Cliffs, NJ 07632, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Surgical Fusion Inc. (Owner Number: 10084995)

Owner / Operator Contact Address

930 Sylvan Ave, Suite 125, Englewood Cliffs, NJ 07632, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171228

PMA Number

N/A

All Registered Proprietary Names

SF Push-in Anchor 2.3 SupraFuser B Ultrasonic Generator SupraFuser B Ultrasonic Handpiece

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-04-25
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2022-04-25
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-04-25

Official Correspondent

Till Gumz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Surgical Fusion Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K203334	Acuitive Technologies, Inc.	The Citrefix Knotless Suture Anchor	2021-02-05
K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	2024-12-03
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23

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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3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
3008868758	EXEL INC. DBA DHL SUPPLY CHAIN (USA)	Mooresville, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022472578. Last updated year: 2026. Please use registration number 3022472578 when referencing this establishment in official correspondence.