FDA.reportPublic FDA data

NILE™ Proximal Fixation System

Primary DI
10888857384156
Brand
NILE™ Proximal Fixation System
Company
VB Spine LLC
Model
SP-2466
Catalog number
SP-2466
Device description
Tensioner
Published
2017-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWIBone fixation cerclage, sublaminar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWIBone Fixation Cerclage, SublaminarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857384156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885738415610888857384156

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
10888857598164Xia® 3 System - Serrato®482614020V482614020V2026-07-24
10888857598171Xia® 3 System - Serrato®482614025V482614025V2026-07-24
10888857598188Xia® 3 System - Serrato®482614030V482614030V2026-07-24
10888857598195Xia® 3 System - Serrato®482614035V482614035V2026-07-24
10888857598201Xia® 3 System - Serrato®482614040V482614040V2026-07-24
10888857598218Xia® 3 System - Serrato®482614045V482614045V2026-07-24
10888857598225Xia® 3 System - Serrato®482614520V482614520V2026-07-24
10888857598232Xia® 3 System - Serrato®482614525V482614525V2026-07-24
10888857598249Xia® 3 System - Serrato®482614530V482614530V2026-07-24
10888857082588CHESAPEAKE Stabilization System3608-900343608-900342022-06-01
10888857461819CASCADIA™ Interbody System6101-2852209NL6-G26101-2852209NL6-G22019-10-31
10888857461888CASCADIA™ Interbody System6101-2852205NL12-G26101-2852205NL12-G22019-10-31
10888857218772CASCADIA™ Interbody System6101-2225008LP-G26101-2225008LP-G22015-12-16
10888857218963CASCADIA™ Interbody System6101-2224512LP-G26101-2224512LP-G22015-12-16
10888857219076CASCADIA™ Interbody System6101-2225014LP-G26101-2225014LP-G22015-12-16
10888857219489CASCADIA™ Interbody System6101-2225508LL8-G26101-2225508LL8-G22015-12-16
10888857219595CASCADIA™ Interbody System6101-2226010LL8-G26101-2226010LL8-G22015-12-16
10888857252820DENALI® Spinal System1301-900391301-900392026-08-28
10888857615724OZARK Cervical Plate SystemPRO-1445PRO-14452026-09-22
10888857037953EVEREST® Spinal System2901-5601002901-5601002026-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-07-18
00190376696140InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376696157InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721699InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721705InvictusALPHATEC SPINE, INC.OWI2026-04-09
00190376721712InvictusALPHATEC SPINE, INC.OWI2026-04-09
00763000881696TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-02-05
00763000881702TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2026-02-05
00840085278518ALTAAstura MedicalOWI2026-02-03
00840085277603ALTAAstura MedicalOWI2026-02-02
00840085278051ALTAAstura MedicalOWI2026-02-02
00840085278068ALTAAstura MedicalOWI2026-02-02
10888857581852NILE™ Alternative Fixation SystemVB Spine LLCOWI2025-03-21
00887517721518VersaTieNuvasive, Inc.OWI2024-11-27
00763000675035TRANSLACE™ Spinal Tethering SystemMEDTRONIC SOFAMOR DANEK, INC.OWI2024-11-04
00193982506216HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506223HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506230HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506247HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506254HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506261HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506278HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506285HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506292HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506445HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506452HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506469HILINEGLOBUS MEDICAL, INC.OWI2024-07-22
00193982506476HILINEGLOBUS MEDICAL, INC.OWI2024-07-22