Identity
- Trade Name
- AdvantageRib FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- AdvantageRib Locking Cap, Large, X-Drive FDA UDI
- Model / Reference
- 323.1207 FDA UDI
- Description
- AdvantageRib Locking Cap, Large, X-Drive FDA UDI
Identifiers
- Catalog Number
- 323.1207 FDA UDI
- Primary DI / UDI-DI
- 00854865007366 FDA UDI
- 510(k) Number
- K141241 FDA UDI
- FDA Product Code
- HRS 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 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
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
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
AdvantageRib by Sig Medical Corp. — 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.
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- Proximal Humeral Locking Plate Ⅱ, Combi-holes — Double Medical Technology Inc. · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- Gorilla Plating System — Paragon 28 · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- ANTHEM — GLOBUS MEDICAL, INC. · Class II
- Gorilla Plating System — Paragon 28 · Class II
- ACUMED — ACUMED LLC · Class II
Cleared under the same submission
K141241 also covers:
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
- AdvantageRib — Sig Medical Corp.
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
- Sig Medical Corp.
Sources (1)
- FDA UDI 1a977be7-d90c-40d4-b27c-2109e87461ad 36 fields · synced Jun 6, 2026