FDA.reportPublic FDA data

ISOLA

Primary DI
10705034011776
Brand
ISOLA
Company
DEPUY SPINE, LLC
Model
50003750
Catalog number
50003750
Device description
ISOLA SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.75 - 4.75 - 50mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141509000
K980485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141509000ISOLA AND EXPEDIUM GROWING SPINE SYSTEMSMedos Sarl2014-08-22PGM
K980485000ISOLA SPINAL SYSTEMAcromed Corp.1998-10-21MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034011776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503401177610705034011776

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034245973CONDUIT2761-01-0152761010152015-09-24
10705034245980CONDUIT2761-01-0102761010102015-09-24
10705034245997CONDUIT2761-01-0052761010052015-09-24
10705034245966CONDUIT2761-01-0302761010302015-09-24
10705034604572CROSSNAV3020-20-0012025-02-14
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840019978484Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978491Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978507Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978514Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978521Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978538Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978545Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978552Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978569Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978576Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978583Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978590Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978606Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978613Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978620Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978637Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978644Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978651Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978668Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978675Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978682Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978699Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978705Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978712Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978729Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978736Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978743Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978750Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978767Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978774Reform TiPRECISION SPINE, INC.KWP2026-11-05