Identity
- Trade Name
- Apelo® / Apelo® MIS FDA UDI
- Generic Name
- Orthopaedic bone calliper FDA UDI
- Device Name
- Measurement Guide FDA UDI
- Model / Reference
- 2010-70-0000 FDA UDI
- Description
- Measurement Guide FDA UDI
Identifiers
- Catalog Number
- 2010-70-0000 FDA UDI
- Primary DI / UDI-DI
- M68120107000000 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic bone calliper 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
Yes
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 bone calliper
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 bone calliper.
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- VerteFIT — Ldr Spine USA · Class I
- Perfix™ MIS — CG MedTech Co., Ltd. · Class I
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 1ab321e3-ecce-4a9c-83ba-a2615ed842c8 35 fields · synced May 30, 2026