FDA.reportPublic FDA data

InterPlate®

Primary DI
00817893021605
Brand
InterPlate®
Company
RSB SPINE LLC
Model
L-Ti
Catalog number
RSB5025
Device description
BONE SCREW - RESCUE
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

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
00817893021605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817893021605008178930216058178930216050817893021605

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
038558909
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986492791CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-09
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00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-08
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