Identity
- Trade Name
- Apelo® / Apelo® MIS FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 8.5mm x 60mm Cannulated Reduction Mono Screw FDA UDI
- Model / Reference
- 1110-03-8560 FDA UDI
- Description
- 8.5mm x 60mm Cannulated Reduction Mono Screw FDA UDI
Identifiers
- Catalog Number
- 1110-03-8560 FDA UDI
- Primary DI / UDI-DI
- M68111100385600 FDA UDI
- 510(k) Number
- K110842 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
Dimensions & Sizes
- Size
- Length — 60 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Apelo® / Apelo® MIS by Atlas Spine Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K110842 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 II | Pending data |
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Manufacturer
- Manufacturer
- Atlas Spine Inc.
Sources (1)
- FDA UDI 8a2648f7-de0a-41e3-abf4-7dc393a4fdc5 37 fields · synced Jun 1, 2026