FDA.reportPublic FDA data

Integrity Delivery Instrument, Bone Staple

Primary DI
M06760001180
Brand
Integrity Delivery Instrument, Bone Staple
Company
Anika Therapeutics, Inc.
Model
6000118
Device description
Integrity bone staple delivery instrument, single-use
Published
2023-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M06760001180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807613393
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817337000050SCS 17-0160000412019-07-22
00817337000074Tactoset60000412019-10-15
00817337000586Integrity Retractable Implant Inserter60001272026-10-05
M06760001200Integrity Delivery Instrument, Tissue Tack60001202023-11-14
00817337000364NanoFx FURS-41012026-05-21
00817337000616Hyalomatrix60002322026-02-22
00817337000418Integrity Implant60001132026-01-05
00817337000425Integrity Implant60001142025-09-19
00866142000007Hydrelle685-0152014-09-30
08033549790738Epifilm Otologic653-20014170002018-02-19
08033549790745Epidisc 2pk Otologic 8mm653-30014171002018-02-19
08033549790752EpiDisc TM Perf Patch Kit653-16014171512018-02-19
08033549790769Merogel Injectable640-023CFN 15180002016-09-24
08033549790974Epifilm Otologic653-20014170002018-11-08
08033549790981Epidisc 2pk Otologic 8mm653-30014171002018-11-08
08033549790998EpiDisc TM Perf Patch Kit653-16014171512018-11-08
08033549791117MEROGEL 2pk 4x4cm65114115170022024-04-18
08033549791124MEROGEL 1PK 4x4cm65114015170002024-04-18
08033549791063Epifilm Otologic653-20014170002022-02-04
08033549790714Merogel Nasal Dressing/Sinus Stent &Otologic Packing 2pk 4x4cm651-14115170022018-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
B0842003000000Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000010Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000020Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000030Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000100Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000110Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000120Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000130Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000200Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000210Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000220Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000230Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000300Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000310Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000320Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000330Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000400Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000410Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000420Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000430Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000500Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000510Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000520Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000530Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000600Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000610Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000620Keos Lumbar InstrumentKEOSLXH2023-02-10