Identity
- Trade Name
- Gibralt® FDA UDI
- Generic Name
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
- Device Name
- POSTERIOR CERVICAL,INLINE COUNTER TORQUE, SST, Medcoat 2000, Silicone FDA UDI
- Model / Reference
- PC-188 FDA UDI
- Description
- POSTERIOR CERVICAL,INLINE COUNTER TORQUE, SST, Medcoat 2000, Silicone FDA UDI
Identifiers
- Primary DI / UDI-DI
- M711PC1880 FDA UDI
- 510(k) Number
- K192354 FDA UDI
- FDA Product Code
- NKG FDA UDIKWP FDA UDI
- GMDN Term
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3075 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic counter-torque/rod-pushing instrument
Gibralt® by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic counter-torque/rod-pushing instrument.
- Streamline OCT — Xtant Medical Holdings, Inc. · Class I
- VIPER — Depuy Spine, Inc. · Class I
- Streamline OCT — Xtant Medical Holdings, Inc. · Class I
- SPIRA®-A Integrated — CAMBER SPINE TECHNOLOGIES · Class I
- Mariner — SeaSpine Orthopedics Corporation · Class I
- General Instrument — ORTHOPEDIATRICS CORP. · Class I
- Malibu — SeaSpine Orthopedics Corporation · Class I
- Matrix — Synthes · Class I
Cleared under the same submission
K192354 also covers:
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
- Gibralt® — Innovasis, Inc.
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
- Innovasis, Inc.
Sources (1)
- FDA UDI 61eb4867-1dde-4597-88eb-b4823f9cb86c 35 fields · synced May 30, 2026