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Data / Medical devices / United States / Stryker Puerto Rico, LLC.

Stryker Puerto Rico, LLC.: FDA-registered device maker in Arroyo, PR, United States, 40 510(k) clearances

Stryker Puerto Rico, LLC. is registered with the FDA (registration 2648666) in Arroyo, PR, United States. It lists 46 device types. The FDA files 40 510(k) clearances under its listings, the newest dated October 29, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Stryker Puerto Rico, LLC.
FDA registration number
2648666
Address
Hwy. 3, KM. 131.2 Las Guasimas Ind. Park, Arroyo, PR, United States, 00714
Owner or operator
STRYKER CORP. (1811755)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
September 27, 1989
Registered through
2027
Brand names listed
0250-070-500 Suction Irrigator 2, 0250-070-520 StrykeFlow 2 With Tip, 0485-840-000 - XL Round Diamond Bur, 4 mm, 0485-860-000 - XL Round Diamond Bur, 5.5 mm, 10MM X 32CM POOL SUCTION TIP, METAL FINISH, 10MM X 32CM POOL SUCTION TIP, NON-REFLECTIVE FINISH, 10MM X 32CM REGULAR TIP, VENTED, METAL FINISH, 10MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Contract manufactureraccessdata.fda.gov
Bone CementLOD2Contract manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Repackager or relabeleraccessdata.fda.gov
Bur, Ear, Nose And ThroatEQJ1Contract manufactureraccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Manufactureraccessdata.fda.gov
Cement ObturatorLZN2Contract manufactureraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, CementKIH1Manufactureraccessdata.fda.gov
Drill, Bone, PoweredDZI2Manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Contract manufacturer, Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Endoscope, NeurologicalGWG2Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Contract manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufacturer, Manufactureraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Contract manufactureraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Manufactureraccessdata.fda.gov
Instrument, BiopsyKNW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentHSZ1Manufactureraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUManufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufactureraccessdata.fda.gov
Lamp, SurgicalFTD2Manufactureraccessdata.fda.gov
Lavage, JetFQH2Contract manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Motor, Drill, ElectricHBC2Manufactureraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Contract manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Repackager or relabeleraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufacturer, Manufactureraccessdata.fda.gov
Rongeur, ManualHAE2Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Staple, Fixation, BoneJDR2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Manufactureraccessdata.fda.gov
Syringe, PistonFMF2Manufactureraccessdata.fda.gov
System, Irrigation, UrologicalLJH2Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Repackager or relabeleraccessdata.fda.gov
Tourniquet, PneumaticKCY1Manufactureraccessdata.fda.gov
Unit, Operative DentalEIA1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufacturer, 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
October 29, 2025K251643Synchfix EVTHTNSubstantially EquivalentWright Medical Technology, Inc. (Stryker Corporation)accessdata.fda.gov
March 31, 2020K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPMLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 11, 2019K190070Sonopet iQ Ultrasonic Aspirator SystemLFLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
December 21, 2018K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
February 26, 2018K180327Stryker iVAS 13g Bone Biopsy KitKNWSubstantially EquivalentStryker Corporationaccessdata.fda.gov
January 25, 2018K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
November 20, 2017K172921Stryker Self-Punching ICONIXMBISubstantially EquivalentStrykeraccessdata.fda.gov
October 5, 2017K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitKNWSubstantially EquivalentStryker Corporationaccessdata.fda.gov
August 24, 2017K171465Stryker Self-Punching ICONIXMBISubstantially EquivalentStrykeraccessdata.fda.gov
March 31, 2017K170098ICONIX TT All Suture AnchorMBISubstantially EquivalentStrykeraccessdata.fda.gov
August 13, 2015K150584Stryker Suture TapeGATSubstantially EquivalentStrykeraccessdata.fda.gov
July 23, 2015K151314CinchLock Flex Knotless Suture AnchorMBISubstantially EquivalentPivot Medicalaccessdata.fda.gov
June 29, 2015K151201Stryker ICONIX with NeedlesMBISubstantially EquivalentStrykeraccessdata.fda.gov
April 17, 2015K150416ProCinch Adjustable Loop DeviceHTYSubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
September 4, 2014K141673IVAS 8 GAUGE BONE BIOPSY KITKNWSubstantially EquivalentStryker Corporationaccessdata.fda.gov
February 28, 2014K133671ICONIX ALL SUTURE ANCHORSMBISubstantially EquivalentStryker Corp.accessdata.fda.gov
October 7, 2013K131769CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MMMBISubstantially EquivalentPivot Medical, Inc.accessdata.fda.gov
May 23, 2013K130430IVAS 10MM AND 15MM BALLOON CATHETERHRXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
April 3, 2013K123942STRYKER IVAS BALLOON CATHETERNDNSubstantially EquivalentStryker Corporationaccessdata.fda.gov
July 26, 2012K120509STRYKER ALL SUTURE ANCHORSMBISubstantially EquivalentStrykeraccessdata.fda.gov
July 18, 2012K1208243.9MM REELX STT SUTURE ANCHOR SYSTEMMBISubstantially EquivalentStryker Corp.accessdata.fda.gov
May 1, 2012K112593STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMERLSubstantially EquivalentStryker Corporationaccessdata.fda.gov
August 26, 2008K073633STRYKER ESSX MICRODEBRIDER SYSTEMERLSubstantially EquivalentStryker Ireland Ltd., Instruments Divisionaccessdata.fda.gov
September 17, 2007K071157STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORSHWCSubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
July 20, 2007K070882STRYKER PEEK TWINLOOP TACMBISubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
May 16, 2007K070758STRYKER PEEK ZIP SUTURE ANCHORMBISubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
May 18, 2005K050753STRYKER DISCMONITORFMFSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
October 25, 2004K042457URO PROLJHSubstantially EquivalentW.O.M. World of Medicine AGaccessdata.fda.gov
June 14, 2004K041310STRYKER WEDGE SUTURE ANCHOR SYSTEMMBISubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
February 5, 2004K03083740 L HIGH FLOW INSUFFLATOR F108HIFSubstantially EquivalentW.O.M. World of Medicine AGaccessdata.fda.gov
January 16, 2004K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMHBESubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
December 17, 2003K032943STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITSKNWSubstantially EquivalentStryker Corp.accessdata.fda.gov
November 7, 2003K032473DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBEHRXSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
August 8, 2003K032117STRYKER TOTAL PERFORMANCE (TPS) SYSTEMDZISubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
May 25, 2001K011381HUMMER IV MICRODEBRIDER SYSTEMERLSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
February 21, 2001K003792STRYKER HEATED INSUFFLATOR TUBE SETHIFSubstantially EquivalentStryker Corp.accessdata.fda.gov
June 30, 1998K981717STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORFTDSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
August 5, 1997K972233STRYKER WEDGE INTERFERENCE SCREW SYSTEMHWCSubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
September 28, 1995K952460STRYKER ACL INTERFERENCE SCREW SYSTEMHWCSubstantially EquivalentStryker Endoscopyaccessdata.fda.gov
August 29, 1991K912190STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYSTJDZSubstantially EquivalentStryker Corp.accessdata.fda.gov

Compare with other makers

Updated October 29, 2025. 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.