Identity
- Trade Name
- Apache AIS-C Standalone FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- 1mm AIS-C Impaction Inserter Cartridge Tip, Small FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 1mm AIS-C Impaction Inserter Cartridge Tip, Small FDA UDI
Identifiers
- Catalog Number
- GAC111-S1 FDA UDI
- Primary DI / UDI-DI
- M719GAC111S10 FDA UDI
- 510(k) Number
- K181295 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
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: Orthopaedic inorganic implant inserter/extractor, reusable
Apache AIS-C Standalone by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
Cleared under the same submission
K181295 also covers:
- AIS-C Standalone System — Genesys Orthopedics Systems LLC
- AIS-C Standalone System — Genesys Orthopedics Systems LLC
- Apache — Genesys Orthopedics Systems LLC
- Apache — Genesys Orthopedics Systems LLC
- Apache — Genesys Orthopedics Systems LLC
- Apache AIS-C Standalone — Genesys Orthopedics Systems LLC
- Apache AIS-C Standalone — Genesys Orthopedics Systems LLC
- Apache AIS-C Standalone — Genesys Orthopedics Systems LLC
- Apache AIS-C Standalone — Genesys Orthopedics Systems LLC
- Apache AIS-C Standalone — Genesys Orthopedics Systems LLC
- Apache AIS-C Standalone — Genesys Orthopedics Systems LLC
- Apache AIS-C Standalone — Genesys Orthopedics Systems LLC
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
- Genesys Orthopedics Systems LLC
Sources (1)
- FDA UDI 0f8be9e5-be24-4501-a0ed-ade7e0687b0e 36 fields · synced May 30, 2026