FDA.reportPublic FDA data

Self-Reinforced Technology

Primary DI
10845854017166
Brand
Self-Reinforced Technology
Company
Conmed Corporation
Model
BXS6216
Catalog number
BXS6216
Device description
1.5 MM BONE FIXATION KIT, SELF-REINFORCED TECHNOLOGY, Ø1.5 X 16 MM
Published
2017-10-18
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
MAIFastener, fixation, biodegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854017160PackageGS12In Commercial Distribution
10845854017166PrimaryGS10
00845854017169Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585401716030845854017160
1084585401716610845854017166
00845854017169008458540171698458540171690845854017169

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, bioabsorbableA device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16Millimeter
Outer Diameter1.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Temperature040 Degrees Celsius
Storage Environment Temperature0104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
20653405990908GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990915GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990922GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990939GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990946GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990953GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606743Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606750Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606767Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606774Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606781Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606798Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606804Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606811Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30