Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617155

FEI Number

1000345108

Entity Name

SUMMIT MEDICAL LTD.

City/State/Country

GLOUCESTERSHIRE, GB

Establishment Address

INDUSTRIAL PARK, BOURTON ON THE WATER, GLOUCESTERSHIRE GL54 2HQ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUMMIT MEDICAL LTD. (Owner Number: 9027741)

Owner / Operator Contact Address

INDUSTRIAL PARK, BOURTON ON THE WATER, GLOUCESTERSHIRE, GB-NOTA GL54 2HQ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HiVac Syringe 9mm Nozzle with Nozzle Extruder MiniMix Delivery Syringe SMDS1C HIVAC 7 Triple Mix C703 ClearMix Triple Vacuum Mixing System 414703 ClearMix Vacuum Mixing System 414701 Cement Mixing and Delivery System - 00-4501-090-00 ClearMix Bone Cement Mixing and Delivery System 414702 HiVac7 with Femoral Cement Pressuriser CP701 6mm Slim Flexible Nozzle 414705 HiVac 7 Bone Cement Mixing and Delivery System - C701 Quick-Vac Vacuum Mixing Bowl MiniMix LV SMLV MiniMix SMMM1 HiVac Bowl B713 Mixing Bowl, Spatula B710 Disposable Surgical Lavage Systems Femoral Cement Pressuriser P721 ANCHORMAN Tibial Ligament Fixation Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	1996-09-05
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	1999-03-19
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2023-06-23
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2021-08-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-07-26
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2020-02-18

Official Correspondent

Liz Hayward

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

SUMMIT MEDICAL LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617155. Last updated year: 2026. Please use registration number 9617155 when referencing this establishment in official correspondence.