Identity
- Trade Name
- Apelo® / Apelo® MIS FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- Head Grooming Tool FDA UDI
- Model / Reference
- 2006-06-0000 FDA UDI
- Description
- Head Grooming Tool FDA UDI
Identifiers
- Catalog Number
- 2006-06-0000 FDA UDI
- Primary DI / UDI-DI
- M68120060600000 FDA UDI
- 510(k) Number
- K072426 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable 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: Bone-resection orthopaedic reamer, reusable
Apelo® / Apelo® MIS by Atlas Spine Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-resection orthopaedic reamer, reusable.
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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 |
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Manufacturer
- Manufacturer
- Atlas Spine Inc.
Sources (1)
- FDA UDI fc3c7d8b-fab0-4ba2-abfe-8205345e25d9 36 fields · synced May 30, 2026