Identity
- Trade Name
- GEO Bone Screw System FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Tissue Protector Drill Guide 1.6mm/2.0mm Double FDA UDI
- Model / Reference
- 22111620 FDA UDI
- Description
- Tissue Protector Drill Guide 1.6mm/2.0mm Double FDA UDI
Identifiers
- Primary DI / UDI-DI
- B471221116200 FDA UDI
- 510(k) Number
- K161904 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Surgical drill guide, single-use
GEO Bone Screw System by Gramercy Extremity Orthopedics, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical drill guide, single-use.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Gramercy Extremity Orthopedics, Llc.
Sources (1)
- FDA UDI 3cdb78ba-612b-456e-ae6b-732ececb3570 36 fields · synced Jun 8, 2026