Identity
- Trade Name
- MicroAire® FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Model / Reference
- CFD-010-0167 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847399006660 FDA UDI
- 510(k) Number
- K042078 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbable
MicroAire® by MicroAire Surgical Instruments LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, bioabsorbable.
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- Fix2Lock — OSTEONIC CO., Ltd. · Class II
- Fixone Hybrid Anchor — AJU PHARM. CO., LTD. · Class II
- RIGIDFIX BIOCRYL — Medos International Sàrl · Class II
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
- MicroAire Surgical Instruments LLC
Sources (1)
- FDA UDI 376114ae-1d86-4580-a67a-d6acf18eb1f6 33 fields · synced Jun 9, 2026