DEVICE: Interspace GV Hip Spacer 60 (08031497003979)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Interspace GV Hip Spacer 60
IHGV60S
In Commercial Distribution

TECRES SPA
08031497003979
GS1

1
435428396 *Terms of Use
TAPERED WEDGE STEM
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
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?
33982 Orthopaedic cement spacer
A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
MBB Bone Cement, Antibiotic
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K252326 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
Length: 96 Millimeter
Device Size Text, specify: diameter of the femoral head: 60mm
CLOSE

Device Record Status
638f13af-7e4e-4b47-822d-ba81a615be45
February 19, 2026
1
February 11, 2026
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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE