Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012770122

FEI Number

3012770122

Entity Name

SPINAL RESOURCES INC

City/State/Country

Fort Lauderdale, FL, US

Establishment Address

5975 North Federal Highway, Suite 250, Fort Lauderdale, FL 33308, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Spinal Resources Inc (Owner Number: 10054229)

Owner / Operator Contact Address

5975 North Federal Highway, Suite 250, Fort Lauderdale, FL 33308, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230482

PMA Number

N/A

All Registered Proprietary Names

S Wire Swedge Pedicle Screw System Swedge Pedicle Screw System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2017-02-24
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2017-02-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-09-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-03-24

Official Correspondent

Bernie Bedor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spinal Resources 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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K223112	Smith & Nephew, Inc.	MAVERICK Mini External Fixation System	2022-12-08

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.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

Registration Number	Establishment Name	Location
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE
8043862	AAP IMPLANTATE AG	BERLIN, DE
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015231789	Arthrex Manufacturing Inc.	Pendleton, SC, US
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012770122. Last updated year: 2026. Please use registration number 3012770122 when referencing this establishment in official correspondence.