Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005304945

FEI Number

3005304945

Entity Name

BONE SUPPORT AB

City/State/Country

LUND Skane, SE

Establishment Address

SCHEELEVAGEN 19, LUND Skane SE-22370, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BONE SUPPORT AB (Owner Number: 9075333)

Owner / Operator Contact Address

SCHEELEVAGEN 19, --, LUND, SE-NOTA SE-22370, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CERAMENT G CERAMENT G CERAMENT BONE VOID FILLER CERAMENT BEAD TRAY CERAMENT BEAD TRAY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRR	Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside	Orthopedic	Class 2	888.3046	2022-06-03
QRR	Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside	Orthopedic	Class 2	888.3046	2024-04-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-12-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-10-28

Official Correspondent

Blerta Shuka

US Agent Details

Mike Roth Business: BONESUPPORT INC Email: mike.roth@bonesupport.com Phone: (781) 9433452

Related Public Records

Same Entity

BONE SUPPORT AB

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
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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3010413864	Nolato Stargard Sp. z o.o.	Stargard Zachodniopomorskie, PL
3007738819	OSferionBiomaterials Corp. Mishima Factory	Sunto-gun Shizuoka, JP
3019403037	HERAEUS MEDICAL LLC - BIORESOBABLES	Yardley, PA, US
3010376334	GEV Co., Ltd.	Eumseong-gun Chungbuk, KR
3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005304945. Last updated year: 2026. Please use registration number 3005304945 when referencing this establishment in official correspondence.