FDA.reportPublic FDA data

FiberFIX

Primary DI
00816537021841
Brand
FiberFIX
Company
NANOVA BIO MATERIALS INC
Model
91223-1
Device description
Interference Screw 12x23
Published
2021-08-21
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
MAIFastener, fixation, biodegradable, soft tissue

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816537021841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816537021841008165370218418165370218410816537021841

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(573)875-6682support@nanovabio.com

Regulatory Flags#

DUNS number
006084093
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816537023012FiberFIX160129-1160129-12026-06-09
00816537023029FiberFIX160135-1160135-12026-06-09
00816537023036FiberFIX160145-1160145-12026-06-09
00816537023043FiberFIX190145-1190145-12026-06-09
00816537023050FiberFIX190155-1190155-12026-06-09
00816537023067FiberFIX190165-1190165-12026-06-09
00816537023234FiberFIX160125-1160125-12026-06-09
00816537021698FiberFIX90723-12021-08-21
00816537021704FiberFIX90730-12021-08-21
00816537021711FiberFIX90735-12021-08-21
00816537021728FiberFIX90823-12021-08-21
00816537021735FiberFIX90830-12021-08-21
00816537021742FiberFIX90835-12021-08-21
00816537021759FiberFIX90923-12021-08-21
00816537021766FiberFIX90930-12021-08-21
00816537021773FiberFIX90935-12021-08-21
00816537021780FiberFIX91023-12021-08-21
00816537021797FiberFIX91030-12021-08-21
00816537021803FiberFIX91035-12021-08-21
00816537021810FiberFIX91123-12021-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867627840Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MAI2026-10-07
20845854655501Argo KnotlessConmed CorporationMAI2026-09-25
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
07290019361206OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361213OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361220OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
00888867304598Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304604Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304789Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304796Arthrex®ARTHREX, INC.MAI2026-07-08
00816537023012FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00888867483927Arthrex®ARTHREX, INC.MAI2025-11-06
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHMAI2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHMAI2025-10-01