Identity
- Trade Name
- Apelo® / Apelo® MIS FDA UDI
- Generic Name
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
- Device Name
- Counter Torque FDA UDI
- Model / Reference
- 2006-01-0000 FDA UDI
- Description
- Counter Torque FDA UDI
Identifiers
- Catalog Number
- 2006-01-0000 FDA UDI
- Primary DI / UDI-DI
- M68120060100000 FDA UDI
- 510(k) Number
- K072426 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic counter-torque/rod-pushing instrument 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic counter-torque/rod-pushing instrument
Apelo® / Apelo® MIS by Atlas Spine Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic counter-torque/rod-pushing instrument.
- Streamline OCT — Xtant Medical Holdings, Inc. · Class I
- VIPER — Depuy Spine, Inc. · Class I
- Streamline OCT — Xtant Medical Holdings, Inc. · Class I
- SPIRA®-A Integrated — CAMBER SPINE TECHNOLOGIES · Class I
- Mariner — SeaSpine Orthopedics Corporation · Class I
- General Instrument — ORTHOPEDIATRICS CORP. · Class I
- Malibu — SeaSpine Orthopedics Corporation · Class I
- Matrix — Synthes · Class I
Cleared under the same submission
K072426 also covers:
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE INC.
- Apelo® / Apelo® MIS — ATLAS SPINE 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atlas Spine Inc.
Sources (1)
- FDA UDI b13de470-e338-4cf7-8836-7ea0390a59b1 36 fields · synced May 30, 2026