Synergy Health Allershausen GmbH

FDA Device Registration & Listing · Allershausen Bavaria, DE · Registration 3010160527

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
3010160527
FEI Number
3002807040
Entity Name
Synergy Health Allershausen GmbH
City/State/Country
Allershausen Bavaria, DE
Establishment Address
Kesselbodenstrasse 7, Allershausen Bavaria 85391, DE
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 10042227)
Owner / Operator Contact Address
5960 Heisley Road, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MedtronicSofamore (AH) - BIPHASIC CALCIUM BO PaulHart16165 (AH) - Atrauman® Ag FKG8620 (DK) - FKG Newclip11561 (MS) - Soft tissues protector Newclip11561 (MS) - BIT, DRILL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2017-02-02
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2013-01-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-20
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2025-12-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-01
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2013-01-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-02-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-12-01
NQO Prosthesis, Spinous Process Spacer/Plate Unknown Class 3 N/A 2021-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-02-06
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-02-09
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2019-02-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-09
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2021-02-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-02-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-02-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-08-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-02-09
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-03-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-02-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-02-09
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-11
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-07
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-08-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-02-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-02-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-03-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-01
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2013-01-09
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2013-03-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-02-09
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-01-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-08-07
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-07
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-03-09
EJL Bur, Dental Dental Class 1 872.3240 2013-12-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-02-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-02-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-02-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2015-09-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-12-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-20
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2017-12-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-02-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2015-12-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-10-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-10-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-10-15
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2024-10-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2016-11-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-11-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-02-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-02-09
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-11-12
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2017-12-16
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2024-11-25
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2024-11-25
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-02-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-02-09
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-15
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-12-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0010-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026 S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil 2
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

Similar Registrations

Registration Number Establishment Name Location
3027338968 RONCADELLE OPERATIONS SRL Castel Mella Brescia, IT
3000214934 ALMAC PHARMA SERVICES LLC Audubon, PA, US
3006850123 JAPAN IRRADIATION SERVICE CO., LTD Naka-gun Ibaraki, JP
3029328631 PEGASUS IMPORTS Houston, TX, US
3010621964 ATLAS MEDICAL PRODUCTS LLC Hialeah, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010160527. Last updated year: 2026. Please use registration number 3010160527 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.