Identity
- Trade Name
- Variable Self-Drilling Screws, 4 mm x 16mm FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Variable Self-Drilling Screws, 4 mm x 16mm FDA UDI
- Model / Reference
- ST06016 FDA UDI
- Description
- Variable Self-Drilling Screws, 4 mm x 16mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- M739ST06016 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
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: Spinal fixation plate, non-bioabsorbable
Variable Self-Drilling Screws, 4 mm x 16mm by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal fixation plate, non-bioabsorbable.
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Cleared under the same submission
K073708 also covers:
- 4-Level Cervical Plates, 102mm — Captiva Spine
- 4-Level Cervical Plates, 106mm — Captiva Spine
- 4-Level Cervical Plates, 110mm — Captiva Spine
- Fixed Self-Drilling Screws, 4 mm x 12mm — Captiva Spine
- Fixed Self-Drilling Screws, 4 mm x 14mm — Captiva Spine
- Fixed Self-Drilling Screws, 4 mm x 16mm — Captiva Spine
- Fixed Self-Drilling Screws, 4 mm x 18mm — Captiva Spine
- Fixed Self-Tapping Screw, 4.5mm x 12mm — Captiva Spine
- Fixed Self-Tapping Screw, 4.5mm x 14mm — Captiva Spine
- Fixed Self-Tapping Screw, 4.5mm x 16mm — Captiva Spine
- Fixed Self-Tapping Screw, 4.5mm x 18mm — Captiva Spine
- Variable Self-Drilling Screws, 4 mm x 12mm — Captiva Spine
K141332 also covers:
- 1-Level Cervical Plates, 20 mm — Captiva Spine
- 1-Level Cervical Plates, 22 mm — Captiva Spine
- 1-Level Cervical Plates, 24 mm — Captiva Spine
- 1-Level Cervical Plates, 26 mm — Captiva Spine
- 1-Level Cervical Plates, 28 mm — Captiva Spine
- 1-Level Cervical Plates, 30 mm — Captiva Spine
- 1-Level Cervical Plates, 32 mm — Captiva Spine
- 1-Level Cervical Plates, 34 mm — Captiva Spine
- 2-Level Cervical Plates, 36 mm — Captiva Spine
- 2-Level Cervical Plates, 38 mm — Captiva Spine
- 2-Level Cervical Plates, 40 mm — Captiva Spine
- 2-Level Cervical Plates, 42 mm — Captiva 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Captiva Spine
Sources (1)
- FDA UDI 90ebdb46-8a8d-4cba-b24b-57367a953e5a 34 fields · synced Jun 1, 2026