Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022159082

FEI Number

3022159082

Entity Name

INFIGO MEDICAL

City/State/Country

Miami, FL, US

Establishment Address

66 west flagler street suite 900, Miami, FL 33130, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

INFIGO MEDICAL (Owner Number: 10084742)

Owner / Operator Contact Address

66 west flagler street, suite 900, Miami, FL 33130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INFIGO INSTRUMENT INFIGO INSTRUMENT TRAUMA INFIGO SPINAL FIXATION SYSTEM INFIGO INSTRUMENT INFIGO INSTRUMENT TRAUMA INFIGO SPINAL FIXATION SYSTEM INFIGO SPINAL FIXATION SYSTEM INFIGO INSTRUMENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2022-03-29
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-03-16
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2026-03-16
HWL	Set, Hollow Mill	Orthopedic	Class 1	888.4540	2026-03-16
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2023-09-25
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2023-09-25
LYQ	Accessories, Fixation, Spinal Intervertebral Body	Orthopedic	Class 1	888.4540	2022-05-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-05-10

Official Correspondent

john ray

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INFIGO 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
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25
K041888	Signus Medizintechnik GmbH	CURVED PEEK TETRIS SPINAL IMPLANT	2004-08-10
K211892	Arftx Medical, LLC	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	2022-10-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	HUMACAO, PR, US
3010049501	JATEX, INC.	Nappanee, IN, US
3011530718	OSTEONIC CO., LTD.	Seoul, KR
3013846070	GREENS SURGICALS PRIVATE LIMITED	Vadodara Gujarat, IN
3006846753	Bradshaw Medical Inc.	Kenosha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022159082. Last updated year: 2026. Please use registration number 3022159082 when referencing this establishment in official correspondence.