Identity
- Trade Name
- Gladstone ALIF Cage FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Model / Reference
- PS1-01-0318 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215019136 FDA UDI
- 510(k) Number
- K172019 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Polymeric spinal fusion cage, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polymeric spinal fusion cage, sterile
Gladstone ALIF Cage by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal fusion cage, sterile.
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- Avenue T — Ldr Spine USA · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
Cleared under the same submission
K172019 also covers:
- ALIF Trial Caddy — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage ALIF Trial Cage — SIGNATURE ORTHOPAEDICS PTY LTD
- Advantage Instrument Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Australis ALIF Cage — SIGNATURE ORTHOPAEDICS 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
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI 960eee9f-c2c7-4c02-b1ed-4ef6565f2a59 33 fields · synced May 30, 2026