Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222773

FEI Number

1000120768

Entity Name

GEOTEC, INC.

City/State/Country

Warwick, RI, US

Establishment Address

89 Bellows St, Warwick, RI 02888, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GeoTec, Inc. (Owner Number: 10042278)

Owner / Operator Contact Address

89 Bellows Street, Warwick, RI 02888, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QuickDraw Bone Harvester CPX Tightening Tool; Cross Pin Fixation System; Tissue Protector Vocal Fold Infusion Needle Nautilus Spinal System Banyan Medical Laparoscopic Instrument Organizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-01-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-12-30
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2017-11-03
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-12-30
KAA	Set, Laryngeal Injection	Ear, Nose, Throat	Class 1	874.4420	2017-11-03
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2017-11-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-12-10
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2017-11-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-11-07
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-11-07
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2022-12-14
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2023-12-28
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2023-12-28
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2025-12-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-12-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2012-11-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-11-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-11-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-11-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-11-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-12-10
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-12-10
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2025-12-10
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2014-12-30
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2022-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-12-30
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2021-12-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-12-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-12-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-12-30
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-12-30
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2012-11-07

Official Correspondent

Thomas Jellison

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GeoTec, 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
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222773. Last updated year: 2026. Please use registration number 1222773 when referencing this establishment in official correspondence.