FDA.reportPublic FDA data

ChronOS

Primary DI
10887587060934
Brand
ChronOS
Company
Synthes GmbH
Model
710.047.98S
Catalog number
71004798S
Device description
CHRONOS(TM) BETA-TCP BLOCK 20MM X 20MM X 10MM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston
GXPMETHYL METHACRYLATE FOR CRANIOPLASTY
LYCBone grafting material, synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
GXPMethyl Methacrylate For CranioplastyNeurology2
LYCBone Grafting Material, SyntheticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041350000
K053022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041350000SYNTHES (USA) CHRONOSSynthes (Usa)2004-07-08GXP
K053022000SYNTHES (USA) CHRONOS-BETA-TCPSynthes (Usa)2006-01-23LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587060934PrimaryGS10
H98071004798S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758706093410887587060934

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
00813954028798Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
00813954028804Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028781Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00812013030291Instylla Delivery KitINSTYLLA INC.FMF2026-03-25
00812013030116Instylla Delivery KitINSTYLLA INC.FMF2025-09-18
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813954026794SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813909010335Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027128PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027135PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027050TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027067TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027074TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027081TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813909013367Dental Putty Cartridge 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013374Dental Putty Cartridge 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013473PerioGlas - 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013480PerioGlas 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013503Dental Putty - 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013510Dental Putty Cartridge 4 x 0.25ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013329Dental Putty Syringe 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013336Dental Putty Syringe 1.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25