FDA.reportPublic FDA data

Xia 3 System - Serrato

Primary DI
07613327353143
Brand
Xia 3 System - Serrato
Company
Stryker Corporation
Model
48260255
Catalog number
48260255
Device description
Navigated Tap
Published
2017-11-09
Public version status
Update
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327353143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327353143076133273531437613327353143

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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
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
00193982622312EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00193982622329EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-21
00885556919712Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919729Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919750Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919774Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924198Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924204Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924211Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924228Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924235Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924242Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924266Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924273Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924297Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
20885556924307NASmith & Nephew, Inc.OLO2026-03-10
07613327627725MakoMAKO SURGICAL CORP.OLO2026-03-10
00840493413228RIVA Posterior Fixation SystemXENIX MEDICAL LLCOLO2026-03-03
07613327683653Shoulder 1.5 Installation DiskMAKO SURGICAL CORP.OLO2026-03-03
10888857563384Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563391Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563407Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563414Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563421Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857578876Q Interbody InstrumentsK2M, INC.OLO2026-03-03