FDA UDI
In Commercial Distribution
🇺🇸 United States
RESTORIS XLVE
DI: 00848486010102
·
Model: 186140-58
·
MAKO SURGICAL CORP.
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RESTORIS XLVE
- Primary DI
- 00848486010102
- Version / Model
- 186140-58
- Catalog Number
- 186140-58
- Company Name
- MAKO SURGICAL CORP.
- Labeler DUNS
- 175239677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- eed3532e-fa4d-4129-a699-df7cb9a12643
Device Description
Acetabular Liner Neutral
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate | Orthopedic | 888.3353 | 2 |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | Orthopedic | 888.3350 | 2 |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | Orthopedic | 888.3353 | 2 |
| OQH | Hip, semi-constrained, cemented, metal/polymer + additive, cemented | Orthopedic | 888.3350 | 2 |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
| OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented | Orthopedic | 888.3353 | 2 |
| OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43168 | Non-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 does not include a stabilizing component to limit the range of motion of the hip. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848486010102 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131237 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Head Diameter: 40.0 Millimeter | ||
| Device Size Text, specify | Diameter: 58.0 Millimeter | ||
| Device Size Text, specify | Diameter: 59.0 Millimeter | ||
| Device Size Text, specify | Diameter: 60.0 Millimeter |