Identity
- Trade Name
- Axon FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- 3.5MM TI CANCELLOUS AXON(TM) SCREW 42MM THREAD LENGTH FDA UDI
- Model / Reference
- 04.200.621 FDA UDI
- Description
- 3.5MM TI CANCELLOUS AXON(TM) SCREW 42MM THREAD LENGTH FDA UDI
Identifiers
- Catalog Number
- 04200621 FDA UDI
- Primary DI / UDI-DI
- 10705034733654 FDA UDI
- 510(k) Number
- K023675 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
The Axon Spinal Bone Screw is a non-bioabsorbable, implantable rod used for internal spinal fixation. It features a screw head adaptor that stabilizes a rod, providing immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities.
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
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI a00d6529-5935-4179-8df3-3267004b3a67 37 fields · synced Jun 28, 2026