FDA.reportPublic FDA data

InterSpace

Primary DI
00850011453469
Brand
InterSpace
Company
OSTEOREMEDIES, LLC
Model
IHBASE
Catalog number
IHBASE
Device description
InterSpace Hip Trial Base
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011453469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011453469008500114534698500114534690850011453469

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079596704
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
00850011453476REMEDY CoCr Modular HeadsRHCCH40RHCCH402026-06-01
00850011453483REMEDY CoCr Modular HeadsRHCCH44RHCCH442026-06-01
00850011453490REMEDY CoCr Modular HeadsRHCCH46RHCCH462026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupRHPAC40RHPAC402026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupRHPAC44RHPAC442026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupRHPAC46RHPAC462026-06-01
00850011453537Remedy Poly+Plus Acetabular CupRHACI38RHACI382026-06-01
00850011453544REMEDY CoCr Modular HeadsRRTHD44RRTHD442026-06-01
00850011453223BioBrushDDBK03DDBK032026-04-20
00855195006616Spectrum GVSPECTRUM40 2018-11-20
00850011453339REMEDY Poly+Plus Tibial Spacer RPPSM13RPPSM132025-12-16
00850011453346REMEDY Poly+Plus Tibial Spacer RPPSM17RPPSM172025-12-16
00850011453353REMEDY Poly+Plus Tibial Spacer RPPMD13RPPMD132025-12-16
00850011453360REMEDY Poly+Plus Tibial Spacer RPPMD17RPPMD172025-12-16
00850011453377REMEDY Poly+Plus Tibial Spacer RPPLG13RPPLG132025-12-16
00850011453384REMEDY Poly+Plus Tibial Spacer RPPLG17RPPLG172025-12-16
00850011453391REMEDY Poly+Plus Tibial Spacer RTPTSM13RTPTSM132025-12-16
00850011453407REMEDY Poly+Plus Tibial Spacer RTPTSM17RTPTSM172025-12-16
00850011453414REMEDY Poly+Plus Tibial Spacer RTPTMD13RTPTMD132025-12-16
00850011453421REMEDY Poly+Plus Tibial Spacer RTPTMD17RTPTMD172025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640177821393Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
07640177821409Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
07640177821416Neo Medical Pedicle screw kitNeo Medical SAFSM2026-07-10
G079IVA22025000Golden Isles Pedicle Screw SystemIntelivation, LLCFSM2026-07-10
G079IVA22026000Golden Isles Pedicle Screw SystemIntelivation, LLCFSM2026-07-10
00840286860086Consensus Knee SystemShalby Advanced Technologies, Inc.FSM2026-07-09
M697X07900081Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FSM2026-07-08
00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
00840456201206JMUJMU DENTAL, INCFSM2026-06-23
00840456201213JMUJMU DENTAL, INCFSM2026-06-23
00840456201220JMUJMU DENTAL, INCFSM2026-06-23
00840456201237JMUJMU DENTAL, INCFSM2026-06-23
00840456201244JMUJMU DENTAL, INCFSM2026-06-23
00840456201251JMUJMU DENTAL, INCFSM2026-06-23
00840456201268JMUJMU DENTAL, INCFSM2026-06-23
00840456206706JMUJMU DENTAL, INCFSM2026-06-23
00840456206713JMUJMU DENTAL, INCFSM2026-06-23
00840456207000JMUJMU DENTAL, INCFSM2026-06-23
00840456214077JMUJMU DENTAL, INCFSM2026-06-23
00840456214084JMUJMU DENTAL, INCFSM2026-06-23