Identity
- Trade Name
- ZESPIN SI Joint Fusion System FDA UDI
- Generic Name
- Intracranial/compartmental-pressure monitor calibrator/cable FDA UDI
- Device Name
- Locking Screw Ø6x65mm FDA UDI
- Model / Reference
- 1023-6065S FDA UDI
- Description
- Locking Screw Ø6x65mm FDA UDI
Identifiers
- Catalog Number
- 1023-6065S FDA UDI
- Primary DI / UDI-DI
- 00840273311836 FDA UDI
- 510(k) Number
- K210035 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Intracranial/compartmental-pressure monitor calibrator/cable 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intracranial/compartmental-pressure monitor calibrator/cable
ZESPIN SI Joint Fusion System by Aegis Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210035 also covers:
- Elatus Lumbar Plate System — Aegis Spine, Inc.
- Elatus Lumbar Plate System — Aegis Spine, Inc.
- Elatus Lumbar Plate System — Aegis Spine, Inc.
- Elatus Lumbar Plate System — Aegis Spine, Inc.
- Elatus Lumbar Plate System — Aegis Spine, Inc.
- Paeon Anterior Cervical Plate System — Aegis Spine, Inc.
- Paeon Anterior Cervical Plate System — Aegis Spine, Inc.
- Paeon Anterior Cervical Plate System — Aegis Spine, Inc.
- Paeon Anterior Cervical Plate System — Aegis Spine, Inc.
- Paeon Anterior Cervical Plate System — Aegis Spine, Inc.
- Paeon Anterior Cervical Plate System — Aegis Spine, Inc.
- Paeon Anterior Cervical Plate System — Aegis 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
- Aegis Spine, Inc.
Sources (1)
- FDA UDI 46c0e8cd-806d-45bf-9a17-b632644b4978 35 fields · synced May 30, 2026