FDA.reportPublic FDA data

Streamline

Primary DI
00810076560038
Brand
Streamline
Company
Xtant Medical Holdings, Inc.
Model
04-CANNDRILL-MDN
Device description
NAV MIS CANN DRILL 3.8mm (D) X 55mm (L)
Published
2021-11-12
Public version status
Update
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
00810076560038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076560038008100765600388100765600380810076560038

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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
081224143
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02
00840311263882Streamline OCT20-MODHANDLE20-MODHANDLE2026-06-04
00840311244874Streamline MIS Spinal Fixation System04-55-PR-10004-55-PR-1002026-06-03
00840311244881Streamline MIS Spinal Fixation System04-55-PR-11004-55-PR-1102026-06-03
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03
00840311244928Streamline MIS Spinal Fixation System04-55-PR-15004-55-PR-1502026-06-03
00840311244935Streamline MIS Spinal Fixation System04-55-PR-16004-55-PR-1602026-06-03
00840311244942Streamline MIS Spinal Fixation System04-55-PR-17004-55-PR-1702026-06-03
00840311245017Streamline MIS Spinal Fixation System04-55-PR-5504-55-PR-552026-06-03
00840311245024Streamline MIS Spinal Fixation System04-55-PR-6004-55-PR-602026-06-03
00840311245062Streamline MIS Spinal Fixation System04-55-PR-8004-55-PR-802026-06-03
00840311245079Streamline MIS Spinal Fixation System04-55-PR-9004-55-PR-902026-06-03
00840311245130Streamline MIS Spinal Fixation System04-55-RR-15004-55-RR-1502026-06-03

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