Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2648666

FEI Number

2648666

Entity Name

STRYKER PUERTO RICO, LLC.

City/State/Country

ARROYO, PR, US

Establishment Address

HWY. 3, KM. 131.2, LAS GUASIMAS IND. PARK, ARROYO, PR 00714, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

STRYKER CORP. (Owner Number: 1811755)

Owner / Operator Contact Address

4100 East Milham Ave., Kalamazoo, MI 49001, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172558

PMA Number

N/A

All Registered Proprietary Names

TPS Console TPS Standard Attachment Brush TPS Micro Drill/Elite Attachment Brush TPS Unidirectional Footswitch STRYKER DISCMONITOR RF 2 PROBES, 90-S MAX RF 2 PROBES, HOOK RF 2 PROBES, LATERAL RF 2 PROBE, MICRO-BRUSH 30 S GRIZZLY FINAL PACKAGING 90-S XL CrossFire 2 90-S Accelerator Stryker Crossfire System STRYKER CONSOLE CUSTOMIZER CROSSFIRE UPGRADE USB DONGLE RF 2 PROBES, 50-S RF 2 PROBE, 90-DEGREE RF 2 PROBES, 90-S FR 2 PROBES, CONTOUR RF 2 PROBES, DIRECT HOOK XL RF 2 PROBES, AARDVARK 50-S XL RF 2 PROBES, MICRO-CLAW SERFAS ENERGY SUPER 90-S Stryker PEEK TwinLoop FLEX Anchors Stryker PEEK TwinLoop ProCinch ProCinch Standard Tension Adjustable Loop ProCinch Reverse Tension Adjustable Loop NexFix IMN Instruments drill Made-To-Order Tornier Simpliciti Shoulder System MaxTorque Compression Staple System Latitude EV Aequalis Perform+ CalcLock MaxLock Tornier Perform Humeral System Tornier Perform Reversed Pangea Torque Limiting Adapter Aequalis Flex Revive Tornier Extraction Tornier Humeral Nail Pangea Platform Hoffmann LRF Stryker PEEK Zip Suture Anchors Stryker Peek Zip Sutrue Anchor 4mm TomCat Shaver Blades 5mm HellCat Shaver Blades Aggressive Max Shaver Blade 3.5mm Dual Edge Shaver Blade 4mm Smooth Bite Shaver Blade 3.5mm Tomcat HC Shaver Blade 4mm Dual Edge Shaver Blade 3.5mm Dual Edge Shaver Blade 5.5mm ATTACHMENTS PKG., DUAL EDGE SHAVER BLADE - 5.5MM HMENTS SURGICAL INSTRUMENT MOTORS AND ACCE SMOOTH BITE SHAVER BLADE - 3.5MM SAW BLADE HLS KNEETEC PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM PCD PREC. SYS LONG TUBE W/VertaPlex HV PCD kit Short tube with Vertaplex HV PCD Kit Long tube with VertaPlex HV Autoplex with Vertaplex HV AutoPlex M4 Kit B: Cement Mixer with VertaPlex ® HV Manifold compatible AutoPlex M4 Kit A: Cement Mixer with VertaPlex ® HV STAINLESS STEEL INSERTER ACM system with cancellous FEMORAL SPONGE PKG 6 Cement Pusher PERCUTANEOUS CEMENT GUN Injector Transfer Tube ALIQUOT DELIVERY SYSTEM Syringe ACM CARTRIDGE & TIPs DUALSPEED CEMENT INJECTION GUN Friction Cement Gun STRYKER CEMENT INJECTOR DUAL SPEED INJECTION GUN REVOLUTION TIPS LATE INJECTION CEMENT GUN Revolution Cement Gun Titanium Wedge Interference Screws ICONIX w/ Needles Titanium IntraLine Anchors PEEK IntraLine Anchors NANOTACK SUTURE ANCHOR NANOTACK FLEX SUTURE ANCHOR CINCHLOCK KNOTLESS SUTURE ANCHOR Pivot NanoTack TT Suture Anchor MIXER ACM PCD MIXEVAC CEMENT MIXERS AND KITS REVOLUTION AUTOPLEX AEQUALIS PERFORM DUAL IRRIGATION ADAPTER, DISPOSABLE (10BX) 5MM X 32CM REGULAR TIP WITH NO HOLES, NON-REFLECTIVE FINISH 5MM X 45CM REGULAR TIP, VENTED, METAL FINISH 5MM X 32CM POOL SUCTION TIP, METAL FINISH 2MM X 34CM REGULAR TIP WITH NO HOLES, METAL FINISH 5MM X 32CM REGULAR TIP, VENTED, METAL FINISH STRYKEFLOW2 WITHOUT TIP (6BX) 5MM X 32CM REGULAR TIP, NON-VENTED, METAL FINISH 5MM X 24CM REGULAR TIP, VENTED, METAL FINISH CORE HUMMER IRRIGATION CASSETTE AHTO SUCTION/IRRIGATION TUBE SET (6BX) 5MM X 45CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH 2 SPIKE GRAVITY FLOW TUBE SET, DISPOSABLE (10BX) STRYKEFLOW SINGLE SPIKE TUBING (6BX) STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) 10MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH ADAPTER FOR DAVOT NEZHAT/DORSEY SUCTION/IRRIGATION PROBES 3MM X 32CM REGULAR TIP, NON-VENTED, METAL FINISH STRYKEFLOW PS, DUAL SPIKE, 10FT OF TUBING (6BX) 10MM X 32CM POOL SUCTION TIP, NON-REFLECTIVE FINISH AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX) FLEXIBLE LASER FIBER GUIDE, 28CM 5MM X 28CM REGULAR TIP, VENTED, METAL FINISH 5MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH 10MM X 32CM REGULAR TIP, VENTED, METAL FINISH 2MM X 32CM REGULAR TIP WITH 1 HOLE, METAL FINISH 10MM X 32CM POOL SUCTION TIP, METAL FINISH 2MM X 32CM REGULAR TIP WITH 2 HOLES, METAL FINISH 5MM X 32CM NON-CONDUCTIVE TIP, VENTED 3MM X 32CM REGULAR TIP, VENTED, METAL FINISH 5MM X 32CM HYDRODISSECTION TIP, NON-REFLECTIVE FINISH PKG.SINUFLOW SUCTION/IRRIGATOR 5MM X 32CM ASPIRATION NEEDLE TIP 10MM X 32CM STONE SCOOPER 5MM X 32CM POOL SUCTION TIP, NON-REFLECTIVE FINISH AHTO SUCTION/IRRIGATION DUAL SPIKE TUBE SET 5MM X 32CM HYDRODISSECTION TIP, METAL FINISH 5MM X 28CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH 4 SPIKE GRAVITY FLOW TUBE SET, DISPOSABLE (10BX) RIGID LASER FIBER GUIDE FLEXIBLE LASER FIBER GUIDE, 32CM Bone Biopsy Kit ICONIX SPEED ICONIX Self Punching Anchor HUMMER IV 4 mm ENT MicroDebrider JAGUAR Stryker Knifelight ICONIX SPEED SharpShooter Handle SUCTION MAT Suction Mat, Comfort,50"X34" WALL SUCTION KIT - CBC STRYKER SUCTION IRRIGATOR Neptune Bronze SUCTION RING WITH TUBING Strykevac SUCTION RING WITHOUT TUBING 0250-070-500 Suction Irrigator 2 0250-070-520 StrykeFlow 2 With Tip SUCTION RING SUCTION MAT,LOW PROFILE50"X34" Synchfix EVT ALPHAVENT KNOTLESS SP, 6.5MM PEEK, ANCHOR ALPHAVENT KNOTLESS SP, 5.5MM PEEK, ANCHOR ALPHAVENT KNOTLESS SP, 4.75MM PEEK, ANCHOR DISPOSABLE CEMENT SCULPS STAINLESS STEEL INSERTER FEMORAL CANAL BRUSH,STANDARD 206-716 w/2 small sculps/pkg Heated Insuflator Tube Set REELX INTERPULSE SURGILAV ACL Disposable Packs Portal Entry Kit General Instruments ORTHOSET 3911-856-565 ALPHAVENT KNOTLESS SP, 6.5MM, BIOCOMPOSITE ANCHOR 3911-856-555 ALPHAVENT KNOTLESS SP, 5.5MM, BIOCOMPOSITE ANCHOR 3911-856-547 ALPHAVENT KNOTLESS SP 4.75MM BIOCOMPOSITE ANCHOR Stryker(R) Consolidated Operating Room Equipment (CORE) System 4cm Angled Irrigation Clip 4cm Straight Irrigation Clip RemB Micro Drill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-04-15
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2007-11-29
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2007-11-29
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-29
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2007-11-29
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2007-11-29
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2007-11-29
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2007-11-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2002-02-20
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2011-12-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-12-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-12-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-12-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-12-14
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-12-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-31
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-31
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2015-08-06
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2006-12-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-12-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2007-12-03
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2004-11-15
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2015-09-10
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-09-10
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2006-01-13
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-01-13
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2000-06-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-12-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-08-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-12-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-12-14
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-12-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-12-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-12-21
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2018-12-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-02-27
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	1995-03-14
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-02-16
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2014-09-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-11-21
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2013-06-03
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-06-03
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2009-04-22
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	1996-02-06
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-08-13
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2008-01-22
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2008-11-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-09-28
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2018-01-30
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-01-30
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2000-01-24
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-04-22
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2020-04-22
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2020-04-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-04-22
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-11-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-11-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-04-26
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2007-12-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-08-13
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	1995-03-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-07-20
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-20
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2006-12-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2006-12-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-05-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-05-23
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2014-07-17
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2017-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003897776	BIOMIMETIC THERAPEUTICS,LLC	FRANKLIN, TN, US
3040801290	Inari Medical, Costa Rica S.A.	Grecia Alajuela, CR
2031049	TMJ Solutions, LLC	San Buenaventura, CA, US
3016573902	Ortho-Space Ltd.	Caesarea Haifa, IL
3010411911	POM Medical, LLC	Moorpark, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3016245399	NPA de Mexico S.de R.L. de C.V.	Tijuana Baja California, MX
3040335671	Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork (County), IE
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648666. Last updated year: 2026. Please use registration number 2648666 when referencing this establishment in official correspondence.