FDA.reportPublic FDA data

HydroSet XT

Primary DI
07613327064261
Brand
HydroSet XT
Company
Stryker Corporation
Model
897003
Catalog number
897003
Device description
Injectable HA Bone Cement
Published
2017-03-21
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

Product Codes#

Code, Name table
CodeName
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327064261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327064261076133270642617613327064261

GMDN Terms#

Term, Definition table
TermDefinition
Bone grafting cannulaA rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131881429OsteoFlo HydroFiber - 1cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881436OsteoFlo HydroFiber - 3cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881443OsteoFlo HydroFiber - 6cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881450OsteoFlo HydroFiber - 12cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131882013Synthetic Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882020Synthetic Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882037Synthetic Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882044Synthetic Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00810131882136Synthetic Fiber Kit - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882143Synthetic Fiber Kit - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882150Synthetic Fiber Kit - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882167Synthetic Fiber Kit - 12ccSURGENTEC, LLCMQV2026-03-09
00810131883751OsteoFlo Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131883768OsteoFlo Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131883775OsteoFlo Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131883782OsteoFlo Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00813909013985Putty Syringe with Cannula 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013961Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00813909013978Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00850009685346Backpack AFVentris MedicalMQV2026-01-02
00850009685353Backpack AFVentris MedicalMQV2026-01-02
00813909013909Putty 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013916Putty 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013930Porous Morsels 1-2mm 10.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013947Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013954Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
05060548020620InteliGraft™BIOSTONE CO. LIMITEDMQV2025-12-10