Identity
- Trade Name
- VERTEFIX FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- MULTI AXIAL PEDICLE SCREW 5.5 X 50 FDA UDI
- Model / Reference
- CZ5550CT FDA UDI
- Description
- MULTI AXIAL PEDICLE SCREW 5.5 X 50 FDA UDI
Identifiers
- Catalog Number
- CZ5550CT FDA UDI
- Primary DI / UDI-DI
- 06009708426062 FDA UDI
- 510(k) Number
- K080075 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDIKWP FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Spinal bone screw, non-bioabsorbableSpinal bone set screwSpinal bone screw head/rod adaptor
Vertefix by Elite Surgical Supplies (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal bone screw head/rod adaptor.
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- DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
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Cleared under the same submission
K080075 also covers:
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD
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
- Elite Surgical Supplies (pty) Ltd
Sources (1)
- FDA UDI c1d04f5d-9726-47f3-ae15-e89eaae56e33 36 fields · synced May 30, 2026