FDA.reportPublic FDA data

InterPlate®

Primary DI
00817893020585
Brand
InterPlate®
Company
RSB SPINE LLC
Model
C-Ti
Catalog number
RSB414
Device description
COVER DRIVER HANDLE
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

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
00817893020585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817893020585008178930205858178930205850817893020585

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
038558909
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03