Identity
- Trade Name
- PivoRod MIS Curved Rod 5.5 x 110 FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Model / Reference
- 2455-3110 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M739245531100 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Bone-screw internal spinal fixation system, non-sterile
The PivoRod MIS Curved Rod 5.5 x 110 is a non-sterile implantable device used for spinal segment immobilization and stabilization in the treatment of various spinal instabilities or deformities, particularly in cases of degenerative disc disease (DDD). This curved rod is designed to provide precise control over its position, allowing for effective pain management and enhanced functional recovery.
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, 6.5 x 70 — 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, 6.5 x 70 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 30 — Captiva Spine
- MIS Cannulated Polyaxial Screw, 7.5 x 40 — Captiva Spine
Authorization Coverage (1 country)
Regulatory Authorizations
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 3c447f0c-f5be-4a62-ab28-e850526191da 33 fields · synced Jun 20, 2026