ZIMMER SURGICAL, INC.

FDA Device Registration & Listing · Dover, OH, US · Registration 1526350

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1526350
FEI Number
1526350
Entity Name
ZIMMER SURGICAL, INC.
City/State/Country
Dover, OH, US
Establishment Address
200 WEST OHIO AVE., Dover, OH 44622, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ZIMMER, INC. (Owner Number: 1822565)
Owner / Operator Contact Address
345 E. Main Street, --, Warsaw, IN 46580, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

intelliCart Intellicart Various bat. and pneum. powered sys., access., attachments UNIVERSAL Intramedullary Attachment UNIVERSAL Dedicated Oscillating Handpiece UNIVERSAL Ream Attachment UNIVERSAL Drill Attachment AO/Hudson Adapter UNIVERSAL Pneumatic Hose UNIVERSAL Electric Power Supply Modular Coupling UNIVERSAL Key Chuck Attachment Washing Caps Sets UNIVERSAL Modular Pneumatic Trigger Handpiece UNIVERSAL Modular Electric/Battery Trigger Handpiece Power cord Key for Key Chuck Attachment Powered Saw and Accessories UNIVERSAL Saw Attachment UNIVERSAL Dedicated Reciprocating Handpiece UNIVERSAL Sterilizable Cord for Electric Power Supply UNIVERSAL Adapter for Pneumatic Hose O-Ring for Pneumatic Hose UNIVERSAL Wire Driver Zimmer Biomet X Series CONTINUUM KNEE SYSTEM (CKS) BONE HARVESTER Ultra battery powerd system, accessories, and attachments Battery Powered System, accessories, and attachments Hose with CPC connector IV Pole / Rollstand Single Port/Dual Bladder Disposable Cuff with PLC Tank Holder Dual Port/Single Bladder Disposable Cuff Dual Port, Single Bladder cuff with PLC and protective sleeve Dual Port/Dual Bladder Disposable Cuff Single Port/Single Bladder Contour Lge Thigh Cuff ATS Cyclindrical Cuff, Single Port/Dual Bladder Dual Port/Single Bladder Contour Lge Thigh Cuff Basket ATS Cylindrical Cuff, Single Port/Single Bladder Retrofit Kit Single Port, Single Bladder cuff with PLC and protective sleeve Dual Port, Dual Bladder, cuff with PLC and protective sleeve Single Port/Dual Bladder Disposable Cuff Protective sleeve for Disposable Cuff ATS Tourniquet Systems Luer Adaptors Single Port/Single Bladder Disposable Cuff Stand Base Hoses ATS Cylindrical Cuff, Dual Port/Dual Bladder ATS Cylindrical Cuff, Dual Port/Single Bladder 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 Curette MONOMER EVACUATIONG BOWL SUPER BOWL Zimmer Vacuum Foot Pumps ICLH (FREEMAN) ANKLE ActiveCare+SFT; ActiveCare+SFT HomeCare ZIMMER CEMENT DISPENS INTRODIGITATOR Breakaway Nozzle ZIMMER BONE CEMENT INJECTOR Meshgraft II Dermatome with Ratchet Meshgraft II Ratchet Handle Zimmer Skin Graft Mesher with Autoclave case and Rachet Handle Zimmer Skin Graft Mesher Meshgraft II Dermacarrier II Skin Graft Carrrier Cysto Adapters Specimen Socks Y Tube 8 Ft Specimen Trap Collector Roll stand Disposable Canister and Lid Powered IV pole UL PP100R CL-200 Cart Lid Hemovac, Drain with Trocar Surgivac PVC with Trocar Universal Y-Connector Compact Evacuator, PVC with Trocar Mini-Snyder Hemovac Evacuator Suction Adaptor PVC Drains with and without Trocar CL500 Ultra Cart Manifold and Cover Infection Control Evacuator, Drain with Bonded Suction Port TP-TUB160 Tandum Tubing Y-Connector Silicone DL-2800 Disposable Lid Bifurcated Drain Extension Y-Tube -Short Evacuators and Tubing, Y Connectors for Drains T-Tube Long Directional Flow Control Evacuators and Collection Bags, PVC w/ Trocar Tri-Tube Evacuator Tubing 2800cc Disposable Collector Silicone Drain with and without Trocar 1800cc Reusable Collector Evacuators w/ Anti Reflux Valves Quad Lumen Drain with Trocar 2800cc Reusable Collector Infection Control Kit Compact Evacuator, Silicone with Trocar 1800cc Disposable Collector Compact Evacuator, Drain with Bonded Suction Port 450ml Bag Mini Snyder Hemovac Infection Control Kit Keels Procedure Pack Raps OSCILLATING SAW BLADE STABLECUT RECIPROCATING SAW BLADE Zimmer Zimmer Biomet X Series Universal Funnel for Aseptic Transfer Kit Universal Battery for Aseptic Transfer Kit Universal Flash Battery Universal Compact Battery Charger Universal Complete Aseptic Transfer Kit with Battery Positioner, Socket Dual Port/Single Bladder Contour Lge Thigh Cuff Dual Port/Single Bladder Disposable Cuff Single Port/Single Bladder Contour Lge Thigh Cuff Protective sleeve for Disposable Cuff Tank Holder ATS Cylindrical Cuff, Single Port/Dual Bladder Basket Single Port, Single Bladder Cuff with PLC and protective sleeve ATS Cylindrical Cuff, Dual Port/Dual Bladder Various Models ATS with LOP Sensor Single Port/Dual Bladder Disposable Cuff with PLC Dual Port, Single Bladder cuff with PLC and protective sleeve ATS4000TS Tourniquet System ATS Cylindrical Cuff, Single Port/Single Bladder Dual Port/Dual Bladder Disposable Cuff Stand Base Single Port/Single Bladder Disposable Cuff ATS Cylindrical Cuff, Dual Port/Single Bladder Hoses Single Port/Dual BLadder Disposable Cuff Dual Port, Dual Bladder, Cuff with PLC and protective sleeve Luer Adapters IntelliCart OUS OptiVu Streamer Coonrad/Morrey Elbow Cement Restric Zim Clip Mini-Clips MASON LEG HOLDER Wilson Convex Frame Alvarado Knee Support and Stabilizing Plate Alvarado Leg Holder II ActiveCare DVT and ActiveCare+SFT System Transposal Safety Station Allen Med Cement Plugs, Z Poly Plug Anatomical Shoulder Combined System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2018-06-28
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2016-12-22
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2012-03-14
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2017-10-31
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-11-01
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-05-26
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-11-01
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2001-05-22
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2019-10-18
FQH Lavage, Jet General Hospital Class 2 880.5475 2001-05-22
HTF Curette General, Plastic Surgery Class 1 878.4800 2003-07-02
OUG Medical Device Data System General Hospital Class 1 880.6310 2021-05-25
JDY Evacuator, Vapor, Cement Monomer Orthopedic Class 1 888.4220 2006-01-30
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-05-03
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2006-01-30
FZW Expander, Surgical, Skin Graft General, Plastic Surgery Class 1 878.4800 1984-12-17
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2014-01-13
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 1986-12-30
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2003-07-02
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1978-03-07
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2012-03-14
KIL Positioner, Socket Orthopedic Class 1 888.4540 2006-05-26
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-11-01
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-11-01
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2013-09-20
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2018-08-01
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2026-01-20
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2007-11-07
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2007-11-07
HXD Clamp General, Plastic Surgery Class 1 878.4800 1978-02-06
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2001-05-22
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-05-03
FLH Washer Of Body Waste Receptacles General Hospital Class 1 880.6800 2012-11-07
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
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2011-03-31
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2011-03-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2011-03-31
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2018-11-01

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
3005751028 Zimmer Trabecular Metal Technology, Inc. Parsippany, NJ, US
3012392319 Zimmer Biomet Canada DFE Mississauga Ontario, CA
2648920 ZIMMER MANUFACTURING B.V. MERCEDITA, PR, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K082762 Aardvark Medical AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE 2008-11-12
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K213616 Becton, Dickinson and Company BD Surgiphor Antimicrobial Irrigation System 2022-03-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-05 Kinetic Concepts, Inc 2
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Z-0020-04 Vital Concepts, Inc. 1
Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04 Vital Concepts, Inc. 1
Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04 Vital Concepts, Inc. 1
HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04 Vital Concepts, Inc. 1
HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526350. Last updated year: 2026. Please use registration number 1526350 when referencing this establishment in official correspondence.
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