Identity
- Trade Name
- Secure IM Nail FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- One 35mm x 1.2mm IM Nail FDA UDI
- Model / Reference
- 8912-35 FDA UDI
- Description
- One 35mm x 1.2mm IM Nail FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857915007316 FDA UDI
- 510(k) Number
- K180087 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Secure IM Nail by A.m. Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
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- IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K180087 also covers:
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
- Secure IM Nail — A.M. SURGICAL, INC.
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
- A.m. Surgical, Inc.
Sources (1)
- FDA UDI 0833078f-c615-469d-869b-2c19591ce6e0 35 fields · synced May 30, 2026