Identity
- Trade Name
- MIS Cannulated Polyaxial Screw, 6.5 x 70 FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Model / Reference
- 2431-6570 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M739243165700 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
MIS Cannulated Polyaxial Screw, 6.5 x 70 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
K122332 also covers:
- Articulating Perc Rod, 5.5 x 35mm — Captiva Spine
- Articulating Perc Rod, 5.5 x 45mm — Captiva Spine
- Articulating Perc Rod, 5.5 x 50mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 6.5 x 75mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 95mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 8.0 x 65mm — Captiva Spine
- MIS Cannulated Polyaxial Screw, 5.5 x 30 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 5.5 x 55 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 40 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 45 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 6.5 x 65 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 30 — Captiva Spine
K131538 also covers:
- Articulating Perc Rod, 5.5 x 35mm — Captiva Spine
- Articulating Perc Rod, 5.5 x 45mm — Captiva Spine
- Articulating Perc Rod, 5.5 x 50mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 5.5 x 50mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 40mm — Captiva Spine
- Cannulated Polyaxial Reduction Screw, 7.5 x 95mm — Captiva Spine
- Curved Rod, 5.5 x 200 — Captiva Spine
- Curved Rod, 5.5 x 220 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 5.5 x 55 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 30 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 40 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 75 — 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 79324e55-a288-4851-914e-6ac4c2e2947a 33 fields · synced Jun 6, 2026