Identity
- Trade Name
- Lapidus Plating System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Lapidus Dorsomedial Bridge Plate 5-Hole, RIGHT Titanium FDA UDI
- Model / Reference
- 12030305 FDA UDI
- Description
- Lapidus Dorsomedial Bridge Plate 5-Hole, RIGHT Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- B471120303050 FDA UDI
- 510(k) Number
- K212334 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Lapidus Plating System by Gramercy Extremity Orthopedics, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K212334 also covers:
- Lapidus Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- Lapidus Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- Lapidus Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- Lapidus Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- Lapidus Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- Lapidus Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
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
- Gramercy Extremity Orthopedics, Llc.
Sources (1)
- FDA UDI 9345e777-5cac-4d39-b15b-2e265c4b5c65 36 fields · synced May 30, 2026