NUTECH SPINE, INC.

FDA Device Registration & Listing · Birmingham, AL, US · Registration 3009169996

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009169996
FEI Number
3009169996
Entity Name
NUTECH SPINE, INC.
City/State/Country
Birmingham, AL, US
Establishment Address
2231 20th Avenue South, Birmingham, AL 35223, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
NuTech Spine, Inc. (Owner Number: 10036081)
Owner / Operator Contact Address
2231 20th Ave South, Suite 101, Birmingham, AL 35223, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K060025
PMA Number
N/A

All Registered Proprietary Names

NuTech Spine Pedicle Screw Spinal System NuFix NuTech NuTech Biologics NuTech Spine SIFix DuALIF NuTech Spine Simplicity Plate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-12-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-12-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-12-14
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2011-04-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2011-12-14

Official Correspondent

Jeremy Barker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NuTech Spine, 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
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009169996. Last updated year: 2026. Please use registration number 3009169996 when referencing this establishment in official correspondence.
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