Navigated Spine Instruments

Primary DI
10888857480971
Brand
Navigated Spine Instruments
Company
VB Spine LLC
Model
6201-N90011-K
Catalog number
6201-N90011-K
Device description
Navigated Awl Taps, 4.0 mm Mesa 2
Published
2021-04-01
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
K203205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203205000Navigated Spine InstrumentsStryker Spine2021-03-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857480971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885748097110888857480971

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
Device count
1
Lot or batch
true
Sterilization required before use
true

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