Identity
- Trade Name
- Anterior Cervical Interbody Fusion Device FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Outer case FDA UDI
- Model / Reference
- 21-1200-OC FDA UDI
- Description
- Outer case FDA UDI
Identifiers
- Catalog Number
- 21-1200-OC FDA UDI
- Primary DI / UDI-DI
- 00840019922128 FDA UDI
- 510(k) Number
- K083118 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable 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
No
FDA UDI
Single Use
No
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
No
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: Orthopaedic surgical procedure kit, non-medicated, reusable
Anterior Cervical Interbody Fusion Device by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
- Knee Instruments — Medacta International · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Spine Instruments — Medacta International · Class I
- Knee Instruments — Medacta International · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- General Instruments — ORTHOPEDIATRICS CORP. · Class I
- Hip Instruments — Medacta International · Class I
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
Cleared under the same submission
K083118 also covers:
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision Spine, Inc.
- Anterior Cervical Interbody Fusion Device — Precision 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
- Precision Spine, Inc.
Sources (1)
- FDA UDI 067d9fb0-d394-4a5e-8f6e-9b4774c21e8f 35 fields · synced Jun 1, 2026