FDA.reportPublic FDA data

REVOLUTION SPINAL SYSTEM

Primary DI
00814033020511
Brand
REVOLUTION SPINAL SYSTEM
Company
INTELLIGENT IMPLANT SYSTEMS, LLC
Model
1166550TL
Catalog number
1166550TL
Device description
6.5 X 50 MM CANNULATED BONE SCREW, TWO-LEVEL
Published
2017-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163056000Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC2017-02-24NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814033020511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814033020511008140330205118140330205110814033020511

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
704-424-1009INFO@INTELLIGENTIMPLANTSYSTEMS.COM

Regulatory Flags#

DUNS number
013742030
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814033021266MEDIANT1213021213022019-05-29
00814033021273MEDIANT1213091213092019-05-29
00814033021280MEDIANT1213081213082019-05-29
00814033020900Mediant Anterior Cervical Plate121010192018-05-17
00814033020917Mediant Anterior Cervical Plate121010202018-05-17
00814033020924Mediant Anterior Cervical Plate121010222018-05-17
00814033020931Mediant Anterior Cervical Plate121010242018-05-17
00814033020948Mediant Anterior Cervical Plate121010262018-05-17
00814033020955Mediant Anterior Cervical Plate121010282018-05-17
00814033020962Mediant Anterior Cervical Plate121010302018-05-17
00814033020979Mediant Anterior Cervical Plate121010322018-05-17
00814033020986Mediant Anterior Cervical Plate121010342018-05-17
00814033020993Mediant Anterior Cervical Plate121010362018-05-17
00814033021006Mediant Anterior Cervical Plate121020372018-05-17
00814033021013Mediant Anterior Cervical Plate121020402018-05-17
00814033021020Mediant Anterior Cervical Plate121020432018-05-17
00814033021037Mediant Anterior Cervical Plate121020462018-05-17
00814033021044Mediant Anterior Cervical Plate121020492018-05-17
00814033021051Mediant Anterior Cervical Plate121020522018-05-17
00814033021068Mediant Anterior Cervical Plate121020552018-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678520297S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520485S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520486S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520487S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520488S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520489S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520490S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520491S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520492S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520493S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520494S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520495S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520496S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02