Identity
- Trade Name
- AccuFit Lateral Plate System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Instrument & Implant Kit - 2 Hole Plate FDA UDI
- Model / Reference
- 58-BK-1001 FDA UDI
- Description
- Instrument & Implant Kit - 2 Hole Plate FDA UDI
Identifiers
- Catalog Number
- 58-BK-1001 FDA UDI
- Primary DI / UDI-DI
- 00840019965910 FDA UDI
- 510(k) Number
- K220324 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbableSpinal fixation plate, non-bioabsorbableOrthopaedic surgical procedure kit, non-medicated, reusable
AccuFit Lateral Plate System by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220324 also covers:
- AccuFit Lateral Plate System — Precision Spine, Inc.
- AccuFit Lateral Plate System — Precision Spine, Inc.
- AccuFit Lateral Plate System — Precision Spine, Inc.
- AccuFit Lateral Plate System — Precision Spine, Inc.
- AccuFit Lateral Plate System — Precision Spine, Inc.
- AccuFit Lateral Plate System — Precision Spine, Inc.
- AccuFit Lateral Plate System — 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 8c6ae999-62e8-4b5c-80ff-6ae63dea3a8f 35 fields · synced May 31, 2026