FDA.reportPublic FDA data

Streamline

Primary DI
00810076560113
Brand
Streamline
Company
Surgalign Spine Technologies, Inc.
Model
04-CANNTAP-85-MDN
Device description
NAV MIS CANNULATED TAP 8.5mm (D)
Published
2021-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K200095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200095000Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2020-06-26OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810076560113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076560113008100765601138100765601130810076560113

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(844) 894-7752customerservice@surgalign.com

Regulatory Flags#

DUNS number
014520584
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850028694596HOLO1540004002023-04-07
00850028694602HOLO1540004012023-04-07
00850028694619HOLO1540004022023-04-07
00850028694626HOLO1540004102023-04-07
00810076562230Cortera150100-400652023-01-06
00810076562247Cortera150100-400702023-01-06
00810076562254Cortera150100-400752023-01-06
00810076562261Cortera150100-400802023-01-06
00810076562278Cortera150100-400852023-01-06
00810076562285Cortera150100-400902023-01-06
00810076562292Cortera150100-400952023-01-06
00810076562308Cortera150100-401002023-01-06
00810076562315Cortera150100-401052023-01-06
00810076562322Cortera150100-401102023-01-06
00810076562339Cortera150100-401152023-01-06
00810076562346Cortera150100-401202023-01-06
00810076562438Cortera150100-450652023-01-06
00810076562445Cortera150100-450702023-01-06
00810076562452Cortera150100-450752023-01-06
00810076562469Cortera150100-450802023-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08