Identity
- Trade Name
- Pedimax II - Pedicular Screw Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- ROD TO ROD CLAMP Ø3,5 / 6,0mm LEFT FDA UDI
- Model / Reference
- Rod to Rod Clamp FDA UDI
- Description
- ROD TO ROD CLAMP Ø3,5 / 6,0mm LEFT FDA UDI
Identifiers
- Catalog Number
- 134-228 FDA UDI
- Primary DI / UDI-DI
- 07899258623108 FDA UDI
- 510(k) Number
- K180626 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Bone-screw internal spinal fixation system connector
Pedimax II - Pedicular Screw Spinal System by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
- Arsenal — ALPHATEC SPINE, INC. · Class II
- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Cleared under the same submission
K180626 also covers:
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Pedimax II - Pedicular Screw Spinal System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
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
- Gm Dos Reis Industria E Comercio Ltda
Sources (1)
- FDA UDI a7dc0583-0323-41ad-bd27-65ab4201358f 35 fields · synced Jun 6, 2026