Identity
- Trade Name
- Polyaxial Screw 8.5 x 80mm FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Model / Reference
- 15112-8580 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7391511285800 FDA UDI
- 510(k) Number
- K160020 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system, non-sterile
Polyaxial Screw 8.5 x 80mm by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K160020 also covers:
- Cannulated Polyaxial Reduction Screw 8.5 x 30mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 8.5 x 35mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 8.5 x 45mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 8.5 x 70mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 8.5 x 85mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 8.5 x 95mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 9.0 x 55mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 9.0 x 60mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 9.0 x 65mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw 9.0 x 80mm — Captiva Spine
- MIS Cannulated Polyaxial Reduction Screw 8.5 x 100mm — Captiva Spine
- MIS Cannulated Polyaxial Reduction Screw 8.5 x 40mm — 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 |
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Manufacturer
- Manufacturer
- Captiva Spine
Sources (1)
- FDA UDI b696b691-bfd1-4f0e-93fa-18baead4eb4a 33 fields · synced Jun 1, 2026