FDA.reportPublic FDA data

Solstice Occipito-Cervico-Thoracic System

Primary DI
00190837014841
Brand
Solstice Occipito-Cervico-Thoracic System
Company
Life Spine, Inc.
Model
9200-17
Published
2016-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090343000SENTINEL SPINAL SYSTEMLife Spine2009-08-11KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837014841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837014841001908370148411908370148410190837014841

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183641617
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837124137Arx17-8575-032026-04-17
00190837124144Arx17-8580-032026-04-17
00190837124151Arx17-8585-032026-04-17
00190837124168Arx17-8590-032026-04-17
00190837124175Arx17-8595-032026-04-17
00190837124243Arx17-9525-032026-04-17
00190837124250Arx17-9530-032026-04-17
00190837124267Arx17-9535-032026-04-17
00190837124274Arx17-9540-032026-04-17
00190837124281Arx17-9545-032026-04-17
00190837124298Arx17-9550-032026-04-17
00190837124304Arx17-9555-032026-04-17
00190837124311Arx17-9560-032026-04-17
00190837124397Arx17-95100-032026-04-17
00190837124403Arx17-95105-032026-04-17
00190837124410Arx17-95110-032026-04-17
00190837124427Arx17-95115-032026-04-17
00190837124434Arx17-95120-032026-04-17
00190837125912Arx17-8575-132026-04-17
00190837125929Arx17-8580-132026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081577ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081584ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081591ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081607ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081614ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081621ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081638ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081645ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081652ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081669ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081676ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081683ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081690ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081706ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081713ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081720ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081737ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081744ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081751ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081768ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081775ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081782ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081799ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081805ZAVATION SCREWZavation LLCKWP2026-06-04