FDA.reportPublic FDA data

Precept

Primary DI
00887517114273
Brand
Precept
Company
Nuvasive, Inc.
Model
8847090P
Device description
PRECEPT Ti Rod, 90mm Prebent
Published
2019-12-09
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171894000NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated2017-09-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517114273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517114273008875171142738875171142730887517114273

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
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
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
00887517656582ReLine13125560131255602026-04-15
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationKWQ2016-09-02
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationKWQ2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationNKB2016-09-02