Identity
- Trade Name
- GMK Sphere Total Knee System FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- GMK Sphere CR Tibial Insert #1L 14mm FDA UDI
- Model / Reference
- 02.12.0114CRL FDA UDI
- Description
- GMK Sphere CR Tibial Insert #1L 14mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630040707138 FDA UDI
- 510(k) Number
- K181635 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tibial insert
GMK Sphere Total Knee System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tibial insert.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
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- Maxim Knee System — Biomet Orthopedics, Inc. · Class II
- Scorpio — Howmedica Osteonics Corp. · Class II
- TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Scorpio — Howmedica Osteonics Corp. · Class II
- World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K181635 also covers:
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
- GMK Sphere Total Knee System — Medacta International
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI 15a09c0e-e125-41ce-8c82-524fa148132f 34 fields · synced Jun 8, 2026