FDA UDI
In Commercial Distribution
🇺🇸 United States
Remedy Spectrum GV Spacer
DI: 00850011453063
·
Model: GVHDXS
·
OSTEOREMEDIES, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Remedy Spectrum GV Spacer
- Primary DI
- 00850011453063
- Version / Model
- GVHDXS
- Catalog Number
- GVHDXS
- Company Name
- OSTEOREMEDIES, LLC
- Labeler DUNS
- 079596704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-30
- Public Version
- 1
- Public Version Date
- 2020-07-08
- Public Version Status
- New
- Public Device Record Key
- 1593e27a-edd9-4024-a946-34db6008c4c2
Device Description
REMEDY SPECTRUM® GV Femoral Head - 40mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | 888.3360 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | 888.3390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011453063 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192995 | 000 |