Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2650143

FEI Number

2648209

Entity Name

STERITECH, INC.

City/State/Country

SALINAS, PR, US

Establishment Address

SALINAS INDUS. PK., LOT 7,, RD. 701, SALINAS, PR 00751, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERITECH, INC. (Owner Number: 2650143)

Owner / Operator Contact Address

SALINAS INDUS. PK., LOT 7,, RD. 701, Salinas, PR 00751, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

D186175 D185254 D186367 D186375 D187800 D186187 D186177 D186171 D186163 D186170 D186166 D186179 D186181 D186374 D186185 D211735 D187836 D186160 D186182 D186164 D187813 D187808 D181316 D186167 D187699 D187803 D186162 D185252 A462871 D186359 D186155 D186159 D186376 D187805 D186361 D186369 D186176 D187815 D187809

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-02-26
JOD	Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4270	2013-02-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-02-27
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2013-02-27
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2013-03-13
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2013-02-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-02-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-26
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-02-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-02-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-02-26
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-02-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-02-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-02-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-26
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-02-26
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2013-02-27
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-02-26
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2014-01-21
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2013-03-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-26
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2013-02-26
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-02-26
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2013-03-13
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2013-03-13
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-02-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-01
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-03-12
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-03-12
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2013-03-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-26
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2013-02-20
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	1992-12-17
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-02-27
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2013-02-26
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2013-02-26
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2013-02-26
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2013-02-27
LPG	Material, Dressing, Surgical, Polylactic Acid	Unknown	Class 3	N/A	2013-03-13
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-02-27
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-02-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-02-26
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2013-03-13
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-03-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERITECH, 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
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2650143. Last updated year: 2026. Please use registration number 2650143 when referencing this establishment in official correspondence.