FDA.reportPublic FDA data

ROSA® Hip CT Instrument Tray - Short

Primary DI
07630055307743
Brand
ROSA® Hip CT Instrument Tray - Short
Company
Incipio Devices SA
Model
50746694
Catalog number
50746694
Device description
Surgical instrument tray
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07630055307743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055307743076300553077437630055307743

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
485098284
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630055307750ROSA® Hip CT Instrument Tray - Tall50746695507466952026-11-05
07630055307736ACE Acetabular Reamer Tray - Instrument Tray50740101507401052026-04-30
07630055307781Positioning handle - M8x1 interface75.70.05775.70.0572026-07-16
07630055307798Positioning handle - M10x1.5 interface75.70.05975.70.0592026-07-16
07630055307804Offset Cup Impactor - M8x1 interface01.15.10.055601.15.10.05562026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interface01.15.10.055501.15.10.05552026-07-16
07630055302458Offset Cup Impactor - M8x1 interface01.15.10.055601.15.10.05562020-04-23
07630055302465Offset Cup Impactor - M10x1.5 interface01.15.10.055501.15.10.05552020-04-23
07630055307026Offset Reamer Handle - Large AO - Tri coupling922061T502445112026-05-07
07630055307033Offset reamer handle - Tri Coupling Transmission922061T-EZ502445102026-05-07
07630055306722Offset reamer handle - Dual Coupling90CH.IN.004502445002026-03-17
07630055306739Offset reamer handle - Large AO motor shaft90CH.IN.AO1502445062026-03-17
07630055306746Offset reamer handle - Stryker Z/H motor shaft90CH.IN.ZH1502445072026-03-17
07630055306753Offset reamer handle - Hudson motor shaft90CH.IN.HU1502445082026-03-17
07630055306760Straight reamer handle - large AO - Dual coupling90ST.IN.AO1502445502026-03-17
07630055306777Straight reamer handle -Stryker Z/H - Dual coupling90ST.IN.ZH1502445512026-03-17
07630055306784Straight reamer handle - Hudson - Dual coupling90ST.IN.HU1502445522026-03-17
07630055306791Offset reamer handle - Dual coupling131-174/05502445002026-03-10
07630055306807Offset reamer handle - Handle131-174/01502445042026-03-10
07630055306814Offset reamer handle - Body131-174/02502445052026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810240701137G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701144G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701151G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
07630055307750ROSA® Hip CT Instrument Tray - TallIncipio Devices SAFSM2026-11-05
10889950159429Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-11-05
00889024713505G7® TM Acetabular SystemZimmer, Inc.FSM2026-11-03
05055662976694Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
05055662976717Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
08800322759509GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704070GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704087Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
08800424704094Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
B382SD9233161140Surgical DirectSurgical Direct, Inc.FSM2026-11-03
00842078100196HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100202HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110133AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02