Identity
- Trade Name
- ASTRA-OCT Spine System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- ASTRA-OCT Angled Left Hook, 6.5mm FDA UDI
- Model / Reference
- A3H-AL65 FDA UDI
- Description
- ASTRA-OCT Angled Left Hook, 6.5mm FDA UDI
Identifiers
- Catalog Number
- A3H-AL65 FDA UDI
- Primary DI / UDI-DI
- 00193082110115 FDA UDI
- 510(k) Number
- K181350 FDA UDI
- FDA Product Code
- KWP FDA UDINKG FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3075 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system hook
The ASTRA-OCT Spine System is a medical device designed to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.
Similar devices
Also classified as Bone-screw internal spinal fixation system hook.
- PERLA ® TL — Spineart · Class II
- Medyssey Spinal System - Deformity — Medyssey Co., Ltd. · Class II
- CD HORIZON® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PASS LP PASS TL — Medicrea International SA · Class II
- DENALI® Spinal System — K2M, INC. · Class II
- MESA® Small Stature Spinal System — K2M, INC. · Class II
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- ReLine — Nuvasive, Inc. · Class II
Cleared under the same submission
K181350 also covers:
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
- ASTRA-OCT Spine System — SPINECRAFT LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spinecraft Llc
Sources (1)
- FDA UDI 41134852-c6f0-4aea-8e19-5e18594670f8 36 fields · synced Jun 20, 2026