Identity
- Trade Name
- ANTHEM FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- ANTHEM Ti Lateral Narrow Distal Femur Plate, Left, 13 Hole, 299mm FDA UDI
- Model / Reference
- 1195.1213 FDA UDI
- Description
- ANTHEM Ti Lateral Narrow Distal Femur Plate, Left, 13 Hole, 299mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00193982456153 FDA UDI
- 510(k) Number
- K213591 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Anthem by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.
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- ACUMED — ACUMED LLC · Class II
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Cleared under the same submission
K213591 also covers:
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
- ANTHEM — GLOBUS MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Globus Medical, Inc.
Sources (1)
- FDA UDI 635674b8-947b-4184-a370-d650f04de065 34 fields · synced May 29, 2026