DEVICE: INSTRUMENT (07613327214307)

Device Identifier (DI) Information

INSTRUMENT
2210-28J
In Commercial Distribution
2210-28J
Howmedica Osteonics Corp.
07613327214307
GS1

1
058311945 *Terms of Use
TRIDENT INSERT TRIAL
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Acetabulum trial prosthesis, reusable A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KWL Prosthesis, hip, hemi-, femoral, metal
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
HWC Screw, fixation, bone
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
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
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 28.0 Millimeter
Device Size Text, specify: Degree: 10.0 Degree
Device Size Text, specify: Alpha Code: J
CLOSE

Device Record Status

e9570794-cd59-49e5-bcdd-2b516a9c1252
July 06, 2018
3
September 24, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE