Identity
- Trade Name
- EASY OUT TOOL FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Model / Reference
- 18665 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810012484206 FDA UDI
- 510(k) Number
- K101030 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic inorganic implant inserter/extractor, single-use
The EASY OUT TOOL is a hand-held manual surgical instrument designed for the precise insertion and/or extraction of non-tissue-based orthopaedic implants, such as bone nails or fixation plates. It features a one-piece or modular configuration with attachments that fit into part of the implant, offering a single-use design.
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.
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- 3.5 X 15.5mm Citrefix XPress System — ACUITIVE TECHNOLOGIES · Class II
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Cleared under the same submission
K101030 also covers:
- 10MM X 3 HBS STD COMP - S. C. — BIOPRO, INC.
- 10mm HBS® High Compression — BIOPRO, INC.
- 10mm x 2.5 HBS Sd Comp — BIOPRO, INC.
- 12MM X 3.0 HBS SCREW SDST PKG — BIOPRO, INC.
- 12mm HBS® High Compression — BIOPRO, INC.
- 13mm HBS® Standard Compression — BIOPRO, INC.
- 13mm x 3 HBS High Comp - S. C. — BIOPRO, INC.
- 14MM X 3.0 HBS SCREW SDST PKG — BIOPRO, INC.
- 14mm HBS® High Compression — BIOPRO, INC.
- 14mm HBS® Standard Compression — BIOPRO, INC.
- 15mm x 2.5 HBS Sd Comp — BIOPRO, INC.
- 16MM X 2.5 HBS STD COMP-S.C. — BIOPRO, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 2c9f34be-69fb-4f75-a2e2-218d38e6a2fd 33 fields · synced Jun 27, 2026