Identity
- Trade Name
- Apelo® / Apelo® MIS FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- MIS Standard Head FDA UDI
- Model / Reference
- 1110-04-0000 FDA UDI
- Description
- MIS Standard Head FDA UDI
Identifiers
- Catalog Number
- 1110-04-0000 FDA UDI
- Primary DI / UDI-DI
- M68111100400000 FDA UDI
- 510(k) Number
- K110842 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone tap, reusable 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
Category: Bone tap, reusable
Apelo® / Apelo® MIS by Atlas Spine Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reusable.
- BIOSURE — Smith & Nephew, Inc. · Class I
- NobelActive® — Nobel Biocare AG · Class I
- CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
- PressON™ — NEXUS SPINE, L.L.C. · Class I
- Insite — TORNIER, INC. · Class I
- ReLine — Nuvasive, Inc. · Class I
- Mariner MIS — SeaSpine Orthopedics Corporation · Class I
- Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
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 22845e95-787b-41b4-8c0b-ef747e18174e 36 fields · synced Jun 8, 2026