FDA.reportPublic FDA data

DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)

Primary DI
04056481145217
Brand
DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)
Company
Brainlab AG
Model
54929
Published
2023-10-17
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
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183605000Spine & Trauma NavigationBrainlab AG2019-08-29OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481145200PrimaryGS10
04056481145217Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481145200040564811452004056481145200
04056481145217040564811452174056481145217

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314482980
Device count
10
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
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
04056481145941Disposable Loop-X Source Drape (1 Pc)22183-122025-07-25
04056481145934Disposable Loop-X Detector Drape (1 Pc)22183-132025-07-24
04056481141677Cirq Robotic Disposable Kinematic Unit56102-01 2022-12-23
04056481145224DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS))41860- 442024-05-22
04056481145231DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS)41860-45 2024-05-22
04056481145248DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS)41860- 462024-05-22
04056481142827Loop-X Disposable Sterile Drape Set22183-012021-10-12
04056481141134Disposable Pre-calibrated Suction Charr. 1252185-012021-03-08
04056481004958Em Disposable Stylet18097180972018-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150057078AXIS AP ROBOTIC TOOL CHANGER 9736681MEDTRONIC NAVIGATION, INC.OLO2026-08-09
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150067626KIT 9736691 SPINE REFERENCINGMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALLMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORTMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989927AXIS HYBRID REF FRAME 9736511MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 9736513MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOLO2026-08-03
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30