| Primary Device ID | 08809763508127 |
| NIH Device Record Key | 6f95085f-a68a-4f66-8908-d9b2ba746b4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INNESIS PEEK CERVICAL CAGE |
| Version Model Number | 42655-08 |
| Company DUNS | 687941818 |
| Company Name | BK MEDITECH CO.,LTD. |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809763508127 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
[08809763508127]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-22 |
| Device Publish Date | 2023-06-14 |
| 08809228122523 | Cervical PEEK Cage, L14 x W16 x H10mm |
| 08809228122516 | Cervical PEEK Cage, L14 x W16 x H9mm |
| 08809228122509 | Cervical PEEK Cage, L14 x W16 x H8mm |
| 08809228122493 | Cervical PEEK Cage, L14 x W16 x H7mm |
| 08809228122486 | Cervical PEEK Cage, L14 x W16 x H6mm |
| 08809228122479 | Cervical PEEK Cage, L14 x W16 x H5mm |
| 08809228122462 | Cervical PEEK Cage, L12 x W14 x H10mm |
| 08809228122455 | Cervical PEEK Cage, L12 x W14 x H9mm |
| 08809228122448 | Cervical PEEK Cage, L12 x W14 x H8mm |
| 08809228122431 | Cervical PEEK Cage, L12 x W14 x H7mm |
| 08809228122424 | Cervical PEEK Cage, L12 x W14 x H6mm |
| 08809228122417 | Cervical PEEK Cage, L12 x W14 x H5mm |
| 08809763508141 | Trial(W1614H10) |
| 08809763508134 | Trial(W16L14H9) |
| 08809763508127 | Trial(W16L14H8) |
| 08809763508110 | Trial(W16L14H7) |
| 08809763508103 | Trial(W16L14H6) |
| 08809763508097 | Trial(W16L14H5) |
| 08809763508080 | Trial(W14L12H10) |
| 08809763508073 | Trial(W14L12H9) |
| 08809763508066 | Trial(W14L12H8) |
| 08809763508059 | Trial(W14L12H7) |
| 08809763508042 | Trial(W14L12H6) |
| 08809763508035 | Trial(W14L12H5) |
| 08809763504709 | Inserter |
| 08809763504693 | Inserter |
| 08809763504440 | Distraction Screw Driver |
| 08809763504433 | Distractor |
| 08809763504426 | Graft Case |
| 08809763504419 | Graft Impactor |
| 08809763504402 | Graft Impactor |
| 08809763504396 | Inserter |
| 08809763503894 | Distraction Screw |
| 08809763505836 | SQ-Adapter Mini I-type Handle |
| 08809763504808 | Graft Impactor |
| 08809763504761 | Graft Case |
| 08809763504747 | Distraction Screw |
| 08809763504730 | Distraction Screw |
| 08809763504723 | Distraction Screw |
| 08809763504716 | Distraction Screw |