Identity
- Trade Name
- Xspan Laminoplasty Fixation System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 12mm PLATE, LAMINOPLASTY, INLINE, with HOOK & FIN, 6mm THROAT FDA UDI
- Model / Reference
- X085-0112-F06-STR FDA UDI
- Description
- 12mm PLATE, LAMINOPLASTY, INLINE, with HOOK & FIN, 6mm THROAT FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X0850112F06STR1 FDA UDI
- 510(k) Number
- K160114 FDA UDI
- FDA Product Code
- NQW FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Depth — 6 Millimeter FDA UDILength — 12 Millimeter FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
Xspan Laminoplasty Fixation System by Xtant Medical Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
- Zavation — ZAVATION · Class II
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
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- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
- Rexious — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K160114 also covers:
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, Inc.
- Xspan Laminoplasty Fixation System — Xtant Medical Holdings, 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
- Xtant Medical Holdings, Inc.
Sources (1)
- FDA UDI 716dc73a-cc1a-44a2-a328-92b5b51d2589 36 fields · synced May 31, 2026