FDA.reportPublic FDA data

STALIF C

Primary DI
00815101023342
Brand
STALIF C
Company
Centinel Spine, LLC
Model
C129581-3T
Published
2017-03-13
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

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120819000STALIF CCentinel Spine, Inc.2012-08-31OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815101023342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815101023342008151010233428151010233420815101023342

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
949024850
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843193102447Prodisc C Instrument03.820.117S2026-09-25
00843193102454Prodisc C, SK, Vivo, Nova Instrument03.820.161S2026-09-25
00843193102461Prodisc C Instrument03.820.153S2026-09-25
00843193102478Prodisc C Instrument03.820.163S2026-09-25
00843193102485Prodisc C Instrument03.820.157S2026-09-25
00843193102492Prodisc C Instrument03.820.167S2026-09-25
00843193102508Prodisc C Instrument03.820.159S2026-09-25
00843193102515Prodisc C Instrument03.820.169S2026-09-25
00843193112699Prodisc C Instrument03.820.1362026-09-25
00843193112705Prodisc C Instrument03.820.1372026-09-25
00843193115300Prodisc C Instrument03.820.130S2026-09-25
00843193115317Prodisc C Instrument03.820.131S2026-09-25
00843193115324Prodisc C Instrument03.820.132S2026-09-25
00843193115331Prodisc C Instrument03.820.133S2026-09-25
00843193115348Prodisc C Instrument03.820.134S2026-09-25
00843193115355Prodisc C Instrument03.820.135S2026-09-25
00843193115362Prodisc C Instrument03.820.140S2026-09-25
00843193115379Prodisc C Instrument03.820.141S2026-09-25
00843193115386Prodisc C Instrument03.820.142S2026-09-25
00843193115706Prodisc C InstrumentIN1545S2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
10888857026582CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
07613327506518Anchor CStryker CorporationOVE2019-12-18
10888857027534CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027541CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027558CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027572CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027589CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027596CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027756CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027763CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027770CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027794CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027800CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027817CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027978CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
04546540679147AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679154AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679161AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679178AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679185AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679192AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679208AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711599AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711605AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711612AVS Anchor-CStryker CorporationOVE2016-09-24