Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019356409

FEI Number

3019356409

Entity Name

INTELIVATION TECHNOLOGIES, LLC

City/State/Country

Plymouth Meeting, PA, US

Establishment Address

500 S Gravers Rd, Suite 200, Plymouth Meeting, PA 19462, US

Establishment Type(s)

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

Owner / Operator

Intelivation Technologies LLC. (Owner Number: 10081899)

Owner / Operator Contact Address

500 S Gravers Rd., Ste 200, Plymouth Meeting, PA 19462, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Screw Depth Measuring Instrument Golden Isles MIS Rod Holder Advantage-LUMBARD Interbody Assembly AOL-07000000 Advantage-LUMBARD Interbody Assembly AOL-00000000 Advantage Lumbar- ALIF, PLIF, DLIF, TLIF Advantage-C Rasp TruTrack Adjustable Drill Guide TruTrack Static Drill Guide 15/18 TruTrack Static Drill Guide 20/25 TruTrack Static Drill Guide 11/13 TruTrack Static Drill Guide 7/9 Golden Isles Pedicle Screw System Advantage-C PEEK Cervical Interbody Fusion Device Impaction Cap Hammerdesis Interphalangeal Fusion System Side to Side Double Domino Connector Golden Isles Pedicle Screw System SET SCREW MIS K-wire 45mm screw Standard Driver Reducer MIS Final Tightener shaft Counter Torque Tap Dilator Detachment Instrument Head Body Manipulator Final Tightening Cuff Head Reamer K wire 500mm SS Blunt Threaded TruTrack Inserter Advantage-C Inserter Advantage-C Trial Advantage-LUMBARD Interbody Working Channel Advantage-LUMBARD Interbody Collar Advantage-LUMBARD Interbody Inserter Assembly MIS Counter Torque Distal Advantage-LUMBAR Interbody Dilator MIS Provisional Locking Cap Driver GI MIS Head Turner K wire 500mm SS MIS Cuff Small Tissue Sweeper GI Set Screw Inserted 1/4" QC K wire 500mm Nitinol Blunt Threaded MIS Distractor (lamina spreader style) Sleeve Screw Dilator INSERTER, SET-SCREW, PALM, T30 T25 Short; Egg Handle Convex TLIF DISC SHAVER ADVANTAGE LUMBAR Advantage-LUMBARD Interbody Funnel Rod Indicator MIS Counter Torque Proximal Advantage-LUMBARD Interbody Graft Pusher MIS Tab Breaker K wire 500mm Nitinol Peg Reamer, Small Peg Reamer, Large Hole Reamer, Large Hole Reamer, Small TruTrack Instrument Kit Hammerdesis Interphalangeal Fusion System Advantage-C Advantage-LUMBARD Interbody Implant Caddy Golden Isles Pedicle Screw System AOL-200 Advantage Lumbar Expandable Disc Shaver Rod Measurement Caliper InteliPowder Tap, Double Lead, 4.5mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2026-01-06
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2025-01-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-13
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2022-01-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-06-04
HXW	Bender	Orthopedic	Class 1	888.4540	2022-04-22
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-01-25
HWA	Impactor	Orthopedic	Class 1	888.4540	2026-01-06
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2023-12-07
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2023-12-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-04-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-06-04
HTO	Reamer	Orthopedic	Class 1	888.4540	2026-01-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-06-04
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-07-25
KTZ	Caliper	Orthopedic	Class 1	888.4150	2026-01-06
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-08-15
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2026-03-23

Official Correspondent

Mark Moldavsky

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intelivation Technologies LLC.

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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019356409. Last updated year: 2026. Please use registration number 3019356409 when referencing this establishment in official correspondence.