FDA.reportPublic FDA data

2.0 × 8.0 mm Screw

Primary DI
M9575000940
Brand
2.0 × 8.0 mm Screw
Company
Nexus Cmf, L.L.C.
Model
500094
Device description
2.0 × 8.0 mm Screw
Published
2014-11-11
Public version status
Update
Distribution status
Not 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
LZDJoint, Temporomandibular, Implant
MPIGlenoid Fossa Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZDJoint, Temporomandibular, ImplantDental3
MPIGlenoid Fossa ProsthesisDental3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9575000940PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965540227
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M957500092055mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000922014-11-11
M9575001090Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)5001092014-10-15
M957500090045mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000902014-11-11
M957500091050mm Stock TMJ Condylar Prosthesis (LEFT SIDE and RIGHT SIDE)5000912014-11-11
M9575001100Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE)5001102014-10-15
M95750042302.7 x 10.0 mm screws [7]5004232014-11-11
M95750009502.0 × 10.0 mm Screw5000952014-11-11
M95750009902.7 × 8.0 mm Screw5000992014-11-11
M95750010002.7 × 10.0 mm Screw5001002014-11-11
M95750010102.7 × 12.0 mm Auxiliary Screw5001012014-11-11
M95750010203.0 × 8.0 mm Auxiliary Screw5001022014-11-11
M95750010303.0 × 10.0 mm Auxiliary Screw5001032014-11-11
M95750010403.0 × 12.0 mm Auxiliary Screw5001042014-11-11
M95750011202.7x8.0mm [2] & 2.7x10.0mm [5] Screws5001122016-09-02
M95750042002.0 x 6.0 mm screws [5]5004202014-11-11
M95750042102.0 x 8.0 mm screws [5]5004212014-11-11
M95750009302.0 × 6.0 mm Screw5000932014-11-11
M95750009702.3 × 8.0 mm Auxiliary Screw5000972014-11-11
M95750009802.3 × 10.0 mm Auxiliary Screw5000982014-11-11
M95750011102.0x6.0mm [1] & 2.0x8.0mm [4] Screws5001112016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327626551Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626568Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626575Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626605Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626650Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626674Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626681Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626698Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626704Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626711Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626728Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626742Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626759Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626766Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626773Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626780Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626797Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626803Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626810Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626827Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626834Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626841Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626858Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626865Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626872Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626889Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626896Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626902Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626919Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11
07613327626926Patient-Fitted TMJ Reconstructive Prosthesis SystemTMJ Solutions, Inc.LZD2023-09-11