Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2648920

FEI Number

1000132037

Entity Name

ZIMMER MANUFACTURING B.V.

City/State/Country

MERCEDITA, PR, US

Establishment Address

ROUTE 1, KM. 123.4, BLDG. 2, TURPEAUX INDUSTRIAL PARK, MERCEDITA, PR 00715, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZIMMER, INC. (Owner Number: 1822565)

Owner / Operator Contact Address

345 E. Main Street, --, Warsaw, IN 46580, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140508

PMA Number

N/A

All Registered Proprietary Names

Trilogy Acet Sys Large Head Liner Mutiple Non-Sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers Gamma System Alpha System CPT Stainless Steel Hip VerSys Cemented Revision/Calcar ZULS 2.7mm Locking Plates and Screw (Ti-6Al-4V Alloy, CP Grade Titanium Zimmer Persona Personalized Knee System-Kinematic Alignment Non-Sterile ZPS Compression,Reconstruction, Symphseal Plates and Forte Screws Trilogy Acetabular System Zimmer Plates and Screws System-Screws only Sterile Intermedics Bone Screw HGP Total Hip CO-CR-MO Alloy Femoral Heritage Hip System Trilogy Acetabular Comp. 7mm Offset Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces Pulsavac tip with shield Pulsavac tip with filter Pulsavac Tips Pulsavac Plus Wound Debridement System Pulsavac Power supply Pulsavac Splash Shields Pulsavac Plus Low Pressure Wound Debridement Systems Pulsavac Connectors Pulsavac Plus AC Wound Debridement System Zimmer Periarticular Screws Zimmer Plates and Screws (ZPS)-Sterile 2.7mm Cortical Screws Zimmer Periarticular Plating System Z ULS 3.5mm Locking Plates and Scre Beta Hip Prosthesis Zimmer Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System Zimmer Knee Joint Replacement Prosthesis MR Labeling Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head Trilogy Acet. Shell & Liners 36mm Zimmer Periarticular Plating System Zimmer, Inc. Hip Joint Prostheses MR Labeling I Zimmer Plates and Screws System (ZPS) Non-sterile Plates and Screws

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-11-09
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2009-08-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-12-15
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-12-15
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2007-11-07
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2007-11-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-11-07
LZN	Cement Obturator	General, Plastic Surgery	Class 2	878.3300	2007-11-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-11-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2018-07-24
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2021-12-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-03-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-03-03
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-06-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-06-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-11-09
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2012-01-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-11-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2009-10-20
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-11-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2007-11-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2007-11-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-11-09
HWT	Template	Orthopedic	Class 1	888.4800	2006-05-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2012-11-09
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2012-11-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-11-09
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2001-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-04-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-12-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-01-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-11-09
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2011-04-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-05-05
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2015-05-05
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2018-04-03
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2018-04-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-04-03
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-04-03
PBI	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive	Orthopedic	Class 2	888.3310	2019-11-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-11-13
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2019-11-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-11-13
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2019-11-13
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2019-11-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-11-13
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2019-11-13
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2019-11-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2007-11-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-03-05
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2020-08-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2020-08-05
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2020-08-05
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2020-08-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2020-08-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2020-08-05
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-08-05
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2020-08-05
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2020-08-05
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-08-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZIMMER, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8031000	ZIMMER SURGICAL SA	1228 Plan Les Ouates Geneve, CH
3020393263	Zimmer U.S., Inc. Connected Health	Grand Rapids, MI, US
1526350	ZIMMER SURGICAL, INC.	Dover, OH, US
3005751028	Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, US
3012392319	Zimmer Biomet Canada DFE	Mississauga Ontario, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

Similar Registrations

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3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
1526534	Sterigenics US, LLC	Lewis Center, OH, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648920. Last updated year: 2026. Please use registration number 2648920 when referencing this establishment in official correspondence.