Identity
- Trade Name
- primaLOK SP FDA UDI
- Generic Name
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- primaLOK SP 15mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. FDA UDI
- Model / Reference
- 800-0115-00 FDA UDI
- Description
- primaLOK SP 15mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813210021761 FDA UDI
- 510(k) Number
- K100354 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 15 Millimeter FDA UDI
Category: Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP by Wenzel Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial.
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Cleared under the same submission
K100354 also covers:
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
- primaLOK SP — Wenzel Spine
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
- Wenzel Spine
Sources (1)
- FDA UDI 3a58cb4f-c407-42a3-911f-2b321dba9f6a 37 fields · synced Jun 8, 2026