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Data / Medical devices / United States / PRO-TECH Design & Mfg, Inc.

PRO-TECH Design & Mfg, Inc.: FDA-registered device maker in Arlington, TX, United States, 1 510(k) clearance and 3 PMA approvals

PRO-TECH Design & Mfg, Inc. is registered with the FDA (registration 3010531069) in Arlington, TX, United States. It lists 29 device types. The FDA files 1 510(k) clearance and 3 PMA approvals under its listings, the newest dated February 20, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3010531069
Address
4041 Express Street, Arlington, TX, United States, 76001
Owner or operator
PRO-TECH Design & Mfg, Inc. (9048910)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
October 15, 2012
Registered through
2026
Brand names listed
DBS Charging System (66700), EPG Pouch with Adhesive (1213), Hemiphalangeal Implant System, Instruments, Surgical, Cardiovascular, Lumbar Charging Apparel (16750), Pectoral Charging Apparel (16760), SCS Charging System (36700)

Devices it lists

DeviceProduct codeClassRoleSource
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Contract manufactureraccessdata.fda.gov
Dorsal Root Ganglion Stimulator For Pain ReliefPMP3Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufactureraccessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOQG2Contract manufactureraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Contract manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufactureraccessdata.fda.gov
Lavage, JetFQH2Contract manufactureraccessdata.fda.gov
Lipoaspirate Washing System For Aesthetic Body ContouringQKL2Contract manufactureraccessdata.fda.gov
Prosthesis, Breast, Inflatable, Internal, SalineFWM3Repackager or relabeleraccessdata.fda.gov
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR3Repackager or relabeleraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
Prosthesis, Toe, Hemi-, PhalangealKWD2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
Set, Administration, IntravascularFPA2Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential TremorPJS3Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian SymptomsNHL3Contract manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY3Contract manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Implanted (Pain Relief)GZB2Contract manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Contract manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Contract manufactureraccessdata.fda.gov
System, Suction, LipoplastyMUU2Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Contract manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 6, 2012K120029HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETKWDSubstantially EquivalentSolana Surgical, LLCaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 20, 2013P040046NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTSFTR29July 26, 2021accessdata.fda.gov
November 17, 2006P020056NATRELLE SILICONE-FILLED BREAST IMPLANTSFTR56September 29, 2026accessdata.fda.gov
May 10, 2000P990074NATRELLE SALINE BREAST IMPLANTSFWM52December 16, 2024accessdata.fda.gov

Compare with other makers

Updated July 26, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.