DEVICE: Screw (07613327036060)
Device Identifier (DI) Information
Screw
6290-7-015
In Commercial Distribution
6290-7-015
Howmedica Osteonics Corp.
6290-7-015
In Commercial Distribution
6290-7-015
Howmedica Osteonics Corp.
Hex Drive Self-Tapping Bone Screw
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 66947 | Orthopaedic bone screw (non-sliding) |
A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| HWC | Screw, fixation, bone |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Diameter: 6.2 Millimeter |
| Length: 15.0 Millimeter |
Device Record Status
e29a8160-b3f1-4e5a-8201-bc93867cbdb8
February 19, 2024
5
September 24, 2015
February 19, 2024
5
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined