Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009165919

FEI Number

3009165919

Entity Name

Kalitec Direct LLC DBA Kalitec Medical

City/State/Country

Sarasota, FL, US

Establishment Address

1819 Main St Ste 303, Sarasota, FL 34236, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Kalitec Medical (Owner Number: 10037099)

Owner / Operator Contact Address

1819 Main St, Suite 303, Sarasota, FL 34236, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NIDO Decorticating Planer NIDO Sagittal Bender, Dbl Ended Left NIDO Sagittal Bender, Dbl Ended Right Awl Tap, Fixed Sleeve Screwdriver, Extended Tab, SNI1 Screwdriver, Tower Tab, Cannulated, SNI2 Screwdriver, Tower Tab, SNI1 Tap, Cannulated, Fixed Sleeve Screwdriver, Tower Tab, Cannulated, SNI1 Tap, Cortical Cannulated, SNI1 Screwdriver, Polyaxial, Standard, Fixed Tap Sleeve Tap, 8.5mm Cortical, SNI1 Kalitec Navigated Instrument System Probe, Lenke, Straight, Fixed Sleeve Screwdriver, Polyaxial, Cannulated, SNI1, Lockable Screwdriver, Extended Tab, Cannulated, SNI1, Lockable Probe, Steffee, Straight, Fixed Sleeve Screwdriver, Modular Bone Screw, SNI1 Screwdriver, Extended Tab, Fixed Tap Sleeve Tap, 4.75mm Cortical, SNI1 Screwdriver, Polyaxial, SNI1, Lockable NIDO T-Handle, T20 Dominoes Cap Starter NIDO T-Handle, T30 Split Tip Cap Starter InSePtion MIS Fixation System NIDO Pedicle Screw System CosmoLock Pedicle Screw System Matira Anterior Cervical System Ocata Anterior Cervical System NIDO Screwdriver, Modular Bone Screws Screwdriver, NIDO Assembled Screws Screwdriver, NIDO Assembled Screws, Sleeved NIDO Screwdriver, Assem Screws SNI1 Tap, 8.5mm Cortical, SNI1 Tap, 4.75mm Cortical, SNI1 Kalitec Disc Prep 3 mm Up Biting Pituitary Kalitec Disc Prep 3 mm Straight Pituitary NIDO Inserter, Dominoes NIDO Inserter, Tulips and Connectors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTZ	Caliper	Orthopedic	Class 1	888.4150	2018-06-21
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2017-01-02
HXW	Bender	Orthopedic	Class 1	888.4540	2018-06-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-08-16
HWA	Impactor	Orthopedic	Class 1	888.4540	2018-06-20
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2017-03-21
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-01-02
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2017-01-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-10-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-10-24
HWT	Template	Orthopedic	Class 1	888.4800	2018-06-20
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2018-06-22
HXC	Wrench	Orthopedic	Class 1	888.4540	2017-01-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-06-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-06-12
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2024-06-12
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-06-22
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2018-06-21
HWJ	Awl	Orthopedic	Class 1	888.4540	2018-06-21
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-06-21
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-01-02
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2017-03-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-09-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-06-20
HXG	Tamp	Orthopedic	Class 1	888.4540	2018-06-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-06-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2017-07-18
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-01-02
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2018-06-21
HTX	Rongeur	Orthopedic	Class 1	888.4540	2019-12-27
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-11-30
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2018-06-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kalitec Medical

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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
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.

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8010273	ACKERMANN INSTRUMENTE GMBH	RIETHEIM, WEILHEIM Baden-Wurttemberg, DE
3012329926	UNITED ORTHOPEDIC CORPORATION	Hsinchu, TW
3008744062	Smith & Nephew, Inc.	Cordova, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009165919. Last updated year: 2026. Please use registration number 3009165919 when referencing this establishment in official correspondence.