Identity
- Trade Name
- Apelo® / Apelo® MIS FDA UDI
- Generic Name
- Bone distraction forceps FDA UDI
- Device Name
- Right Offset Distractor Tip FDA UDI
- Model / Reference
- 2006-55-0000 FDA UDI
- Description
- Right Offset Distractor Tip FDA UDI
Identifiers
- Catalog Number
- 2006-55-0000 FDA UDI
- Primary DI / UDI-DI
- M68120065500000 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone distraction forceps 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: Bone distraction forceps
Apelo® / Apelo® MIS by Atlas Spine Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f8a8caa9-fd46-4f28-ae4d-ee73e1220bfa 35 fields · synced Jun 8, 2026