FDA.reportPublic FDA data

InterPlate®

Primary DI
00817893020660
Brand
InterPlate®
Company
RSB SPINE LLC
Model
C-Ti
Catalog number
RSB423
Device description
IMPACTOR
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
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

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
00817893020660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817893020660008178930206608178930206600817893020660

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. 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
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17
10381780408451Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780479406Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780266389Integra™Allograft Wedge SystemAscension Orthopedics, Inc.HWA2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HWA2018-04-13
10381780279495K2™ Hemi Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780279907KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780224815Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224822Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224839Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224846Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224853Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224860Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224877Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224884Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224891Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780278283Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HWA2018-03-09
10381780278290Integra® Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.HWA2018-03-09