FDA.reportPublic FDA data

InterPlate®

Primary DI
00817893020738
Brand
InterPlate®
Company
RSB SPINE LLC
Model
C-Ti
Device description
SCREW CADDY
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071922000INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGCRsb Spine, LLC2007-09-18OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817893020738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817893020738008178930207388178930207380817893020738

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
038558909
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817893023883Suction Tube Atraumatic 4 FR 125MM10042MA2026-04-22
00817893023890Suction Tube Atraumatic 6 FR 125MM10043MA2026-04-22
00817893023906Suction Tube Atraumatic 8 FR 125MM10044MA2026-04-22
00817893023913Suction Tube Atraumatic 10 FR 125MM10045MA2026-04-22
00817893023920Suction Tube Atraumatic 4 FR 150MM10046MA2026-04-22
00817893023937Suction Tube Atraumatic 6 FR 150MM10047MA2026-04-22
00817893023944Suction Tube Atraumatic 8 FR 150MM10048MA2026-04-22
00817893023951Suction Tube Atraumatic 10 FR 150MM10049MA2026-04-22
00817893023968Suction Tube Atraumatic 4 FR 170MM10050MA2026-04-22
00817893023975Suction Tube Atraumatic 6 FR 170MM10051MA2026-04-22
00817893023982Suction Tube Atraumatic 8 FR 170MM10052MA2026-04-22
00817893023999Suction Tube Atraumatic 10 FR 170MM10053MA2026-04-22
00817893024002Suction tube Malleable Gold Tip, 6 FR, 125 MM10054MA2026-04-22
00817893024019Suction tube Malleable Gold Tip, 8 FR, 125 MM10055MA2026-04-22
00817893024026Suction tube Malleable Gold Tip, 10 FR, 125 MM10056MA2026-04-22
00817893024033Suction tube Malleable Gold Tip, 12 FR, 125 MM10057MA2026-04-22
00817893024040Suction tube Malleable Gold Tip, 6 FR, 150 MM10058MA2026-04-22
00817893024057Suction tube Malleable Gold Tip, 8 FR, 150 MM10059MA2026-04-22
00817893024064Suction tube Malleable Gold Tip, 10 FR, 150 MM10060MA2026-04-22
00817893024071Suction tube Malleable Gold Tip, 12 FR, 150 MM10061MA2026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS186950Aligned Medical SolutionsAligned Medical SolutionsOJH2026-08-03
10198956372849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956423824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956439429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956483613CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956495333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956497849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956500150CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503106CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956506824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512566CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956516076CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956518728CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521230CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523777CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523838CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956529601CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956532380CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533455CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533868CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534216CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534445CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534995CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956535138CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31