Identity
- Trade Name
- GEO Bone Screw System FDA UDI
- Generic Name
- Orthopaedic bone washer, sterile FDA UDI
- Device Name
- Washer for 4mm Bone Screw FDA UDI
- Model / Reference
- 28000004 FDA UDI
- Description
- Washer for 4mm Bone Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- B471280000040 FDA UDI
- 510(k) Number
- K161904 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Orthopaedic bone washer, 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone washer, sterile
GEO Bone Screw System by Gramercy Extremity Orthopedics, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone washer, sterile.
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- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
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- FLAT WASHER6.5MM — Biomet Orthopedics, Inc. · Class II
- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- RONDO' — Citieffe · Class II
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- SURFIX — Newdeal Sas · Class II
Cleared under the same submission
K161904 also covers:
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- GEO Bone Screw 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 536e9a23-2c2e-4d0a-bf5b-ad7124306354 36 fields · synced Jun 6, 2026