DEVICE: Omnifit (07613327021486)

Device Identifier (DI) Information

Omnifit
2006-2652
In Commercial Distribution
2006-2652
Howmedica Osteonics Corp.
07613327021486
GS1

1
058311945 *Terms of Use
20 Degree Series I Insert
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Constrained polyethylene acetabular liner A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JDL Prosthesis, hip, semi-constrained (metal cemented acetabular component)
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K850352 000
K900438 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 26.0 Millimeter
CLOSE

Device Record Status

ba9af163-10b4-4b06-90c5-c013c09aa0a9
July 06, 2018
3
September 24, 2015
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