FDA.reportPublic FDA data

NA

Primary DI
00848486002794
Brand
NA
Company
MAKO SURGICAL CORP.
Model
111670
Catalog number
111670
Device description
BONE PINS (3.2MM X 80MM)
Published
2016-09-24
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486002794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486002794008484860027948484860027940848486002794

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length80Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175239677
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
07613327627725MakoShoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.17000028873152026-03-10
07613327683653Shoulder 1.5 Installation Disk7000043787467000043787462026-03-03
07613327595482Scapular Clamp1906611906612026-01-30
07613327595567Robotic Arm Array MountRobotic Arm Array Mount2906502026-01-30
07613327595772Shoulder irrigation Clip, SterileShoulder irrigation Clip, Sterile1906812026-01-30
07613327623277Lower Tray, Mako Shoulder Tray7000026060227000026060222026-01-30
07613327623284Double Tier Tray Outer Shell7000026060117000026060112026-01-30
07613327625530MAKO Knee Tray Bottom Insert7000026060137000026060132026-01-30
07613327522006Mako7000006250597000006250592026-01-14
07613327595505Mako Glenoid RetractorSmall1906652026-01-08
07613327595741Black Probe1906641906642026-01-08
07613327523874Mako2104902104902025-02-06
07613327627220Mako1906711906712024-11-18
07613327627565Mako1025-200-0751025-200-0752024-11-18
07613327627572Mako1020-200-0751020-200-0752024-11-18
07613327626971Mako1.01906872024-11-15
07613327627213Mako1.01906702024-11-15
07613327625868INSTRUMENT7000021128907000021128902024-10-04
07613327625875INSTRUMENT7000021500957000021500952024-10-04
07613327624304NA2299992299992024-09-18

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