FDA.reportPublic FDA data

InterPlate®

Primary DI
00817893020714
Brand
InterPlate®
Company
RSB SPINE LLC
Model
C-Ti
Catalog number
RSB438
Device description
ROUND HOLE GUIDE - SHORT
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, 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
00817893020714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817893020714008178930207148178930207140817893020714

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. 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
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02
00889024707382Persona Tensor Sizer Arm – LongZimmer, Inc.FZX2026-05-29
00889024707399Persona Tensor Sizer Arm – StdZimmer, Inc.FZX2026-05-29
00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17