| Primary Device ID | 18435711005218 |
| NIH Device Record Key | d90b6e4e-226f-4fea-8475-1a95c5b7f864 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APOLLO Ankle Fracture Plating System |
| Version Model Number | F5-4515-090 |
| Catalog Number | F5-4515-090 |
| Company DUNS | 081102081 |
| Company Name | Glw, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18435711005218 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18435711005218]
Moist Heat or Steam Sterilization
[18435711005218]
Moist Heat or Steam Sterilization
[18435711005218]
Moist Heat or Steam Sterilization
[18435711005218]
Moist Heat or Steam Sterilization
[18435711005218]
Moist Heat or Steam Sterilization
[18435711005218]
Moist Heat or Steam Sterilization
[18435711005218]
Moist Heat or Steam Sterilization
[18435711005218]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-07 |
| Device Publish Date | 2025-01-30 |
| 18435711005218 | T15 self-retaining driver |
| 18435711004938 | Apollo Ankle Fracture Plates / Apollo Lag Drill Kit Ø4.5 / for Screw 4.3 |
| 18435711004921 | Apollo Ankle Fracture Plates / Apollo Lag Drill Kit Ø4.0 / for Screw 3.7 |
| 18435711004914 | Apollo Ankle Fracture Plates / Apollo Lag Drill Kit Ø3.35 / for Screw 2.9 |
| 18435711004907 | Apollo Ankle Fracture Plates / Apollo K-wire Kit Ø1.6 / Single Use Kit |
| 18435711004891 | Apollo Ankle Fracture Plates / Apollo Single Use Kit / Drills & Olive Wires |
| 18435711004785 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x67.5mm |
| 18435711004778 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x62.5mm |
| 18435711004761 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x57.5mm |
| 18435711004754 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x52.5mm |
| 18435711004747 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x47.5mm |
| 18435711004730 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x42.5mm |
| 18435711004723 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x37.5mm |
| 18435711004716 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x32.5mm |
| 18435711004709 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x30mm |
| 18435711004693 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x27.5mm |
| 18435711004686 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x25mm |
| 18435711004679 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x38mm |
| 18435711004662 | APOLLO Ankle Fracture Plates / 3.7mm / Non-Locking Screw / 3.7x38mm |
| 18435711004655 | APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9x08mm |
| 18435711004648 | APOLLO Ankle Fracture Plates / 2.9mm / Non-Locking Screw / 2.9x08mm |
| 18435711004631 | Apollo Ankle Fracture Plates / Lag Kit / 4.3 screw |
| 18435711004624 | Apollo Ankle Fracture Plates / Lag Kit / 3.7 screw |
| 18435711004600 | APOLLO Ankle Fracture Plates / Washer / 7.5mm OD |
| 18435711004433 | Apollo Ankle Fracture Plates / Sterile Trial Package / |
| 18435711004402 | Apollo Ankle Fracture Plates / Single Use Hook Kit / |
| 18435711004327 | Apollo Ankle Fracture Plates / Lag Kit / 2.9 screw |
| 18435711004228 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x70mm |
| 18435711004211 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x65mm |
| 18435711004204 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x60mm |
| 18435711004198 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x55mm |
| 18435711004181 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x50mm |
| 18435711004174 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x45mm |
| 18435711004167 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x40mm |
| 18435711004150 | APOLLO Ankle Fracture Plates / 4.3mm / Non-Locking Screw / 4.3x35mm |
| 18435711004143 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x60mm |
| 18435711004136 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x57.5mm |
| 18435711004129 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x55mm |
| 18435711004112 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x52.5mm |
| 18435711004105 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x50mm |
| 18435711004099 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x47.5mm |
| 18435711004082 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x45mm |
| 18435711004075 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x42.5mm |
| 18435711004068 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x40mm |
| 18435711004051 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x36mm |
| 18435711004044 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x34mm |
| 18435711004037 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x32mm |
| 18435711004020 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x30mm |
| 18435711004013 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x28mm |
| 18435711004006 | APOLLO Ankle Fracture Plates / 3.7mm / Locking Screw / 3.7x26mm |