FDA.reportPublic FDA data

OvertureTi

Primary DI
00810129551389
Brand
OvertureTi
Company
Overture Orthopaedics
Model
90-OVR-640017
Published
2023-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810129551389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810129551389008101295513898101295513890810129551389

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119105665
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810129551198OvertureTi90-OVR-5700172023-10-25
00810129551211OvertureTi90-OVR-5700222023-10-25
00810129551846OvertureTi90-S01-1022502025-07-23
00810129551723OvertureTiPKG-90-OSP-1017302025-03-14
00810129551730OvertureTiPKG-90-OSP-1020352025-03-14
00810129551747OvertureTiPKG-90-OSP-1022402025-03-14
00810129551754OvertureTiPKG-90-OSP-2000172025-03-14
00810129551761OvertureTiPKG-90-OSP-2000222025-03-14
00810129551778OvertureTiPKG-90-OSP-2000252025-03-14
00810129551785OvertureTiPKG-90-OSP-3600172025-03-14
00810129551792OvertureTiPKG-90-OSP-3600202025-03-14
00810129551808OvertureTiPKG-90-OSP-3600222025-03-14
00810129551815OvertureTiPKG-90-OSP-4000002025-03-14
00810129550221OvertureTiPKG-90-OVR-3500172024-12-06
00810129550238OvertureTiPKG-90-OVR-3500202024-12-06
00810129550245OvertureTiPKG-90-OVR-3500222024-12-06
00810129550467OvertureTi90-OVR-5100172023-10-25
00810129550481OvertureTi90-OVR-5100222023-10-25
00810129550498OvertureTi90-OVR-5100252023-10-25
00810129550528OvertureTi90-OVR-5117302023-10-25

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Primary DI, Brand, Company table
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