| Primary Device ID | 00846468086503 |
| NIH Device Record Key | f2dff67b-2d95-4c58-bf58-89ba96d8f6d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortilink-TS IBF System |
| Version Model Number | 65-TS-Case |
| Catalog Number | 65-TS-Case |
| Company DUNS | 793384496 |
| Company Name | Pioneer Surgical Technology, 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846468086503 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
[00846468086503]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2017-10-30 |
| 00846468086503 | Fortilink-TS IBF System Instrument Case |
| 00846468084981 | Fortilink-TS IBF System Tamp, Corner |
| 00846468084912 | Fortilink-TS IBF System Trial Spacer, 17mm (H), 32mm (L) |
| 00846468084905 | Fortilink-TS IBF System Trial Spacer, 16mm (H), 32mm (L) |
| 00846468084899 | Fortilink-TS IBF System Trial Spacer, 15mm (H), 32mm (L) |
| 00846468084882 | Fortilink-TS IBF System Trial Spacer, 14mm (H), 32mm (L) |
| 00846468084875 | Fortilink-TS IBF System Trial Spacer, 13mm (H), 32mm (L) |
| 00846468084868 | Fortilink-TS IBF System Trial Spacer, 12mm (H), 32mm (L) |
| 00846468084851 | Fortilink-TS IBF System Trial Spacer, 11mm (H), 32mm (L) |
| 00846468084844 | Fortilink-TS IBF System Trial Spacer, 10mm (H), 32mm (L) |
| 00846468084837 | Fortilink-TS IBF System Trial Spacer, 17mm (H), 26mm (L), 6° Lordosis |
| 00846468084820 | Fortilink-TS IBF System Trial Spacer, 16mm (H), 26mm (L), 6° Lordosis |
| 00846468084813 | Fortilink-TS IBF System Trial Spacer, 15mm (H), 26mm (L), 6° Lordosis |
| 00846468084806 | Fortilink-TS IBF System Trial Spacer, 14mm (H), 26mm (L), 6° Lordosis |
| 00846468084790 | Fortilink-TS IBF System Trial Spacer, 13mm (H), 26mm (L), 6° Lordosis |
| 00846468084783 | Fortilink-TS IBF System Trial Spacer, 12mm (H), 26mm (L), 6° Lordosis |
| 00846468084776 | Fortilink-TS IBF System Trial Spacer, 11mm (H), 26mm (L), 6° Lordosis |
| 00846468084769 | Fortilink-TS IBF System Trial Spacer, 10mm (H), 26mm (L), 6° Lordosis |
| 00846468084752 | Fortilink-TS IBF System Trial Spacer, 9mm (H), 26mm (L), 6° Lordosis |
| 00846468084745 | Fortilink-TS IBF System Trial Spacer, 8mm (H), 26mm (L), 6° Lordosis |
| 00846468084738 | Fortilink-TS IBF System Trial Spacer, 17mm (H), 26mm (L) |
| 00846468084721 | Fortilink-TS IBF System Trial Spacer, 16mm (H), 26mm (L) |
| 00846468084714 | Fortilink-TS IBF System Trial Spacer, 15mm (H), 26mm (L) |
| 00846468084707 | Fortilink-TS IBF System Trial Spacer, 14mm (H), 26mm (L) |
| 00846468084691 | Fortilink-TS IBF System Trial Spacer, 13mm (H), 26mm (L) |
| 00846468084684 | Fortilink-TS IBF System Trial Spacer, 12mm (H), 26mm (L) |
| 00846468084677 | Fortilink-TS IBF System Trial Spacer, 11mm (H), 26mm (L) |
| 00846468084660 | Fortilink-TS IBF System Trial Spacer, 10mm (H), 26mm (L) |
| 00846468084653 | Fortilink-TS IBF System Trial Spacer, 9mm (H), 26mm (L) |
| 00846468084646 | Fortilink-TS IBF System Trial Spacer, 8mm (H), 26mm (L) |
| 00846468084639 | Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L), 6° Lordosis |
| 00846468084622 | Fortilink-TS IBF System Trial Spacer, 16mm (H), 22mm (L), 6° Lordosis |
| 00846468084615 | Fortilink-TS IBF System Trial Spacer, 15mm (H), 22mm (L), 6° Lordosis |
| 00846468084608 | Fortilink-TS IBF System Trial Spacer, 14mm (H), 22mm (L), 6° Lordosis |
| 00846468084592 | Fortilink-TS IBF System Trial Spacer, 13mm (H), 22mm (L), 6° Lordosis |
| 00846468084585 | Fortilink-TS IBF System Trial Spacer, 12mm (H), 22mm (L), 6° Lordosis |
| 00846468084578 | Fortilink-TS IBF System Trial Spacer, 11mm (H), 22mm (L), 6° Lordosis |
| 00846468084561 | Fortilink-TS IBF System Trial Spacer, 10mm (H), 22mm (L), 6° Lordosis |
| 00846468084554 | Fortilink-TS IBF System Trial Spacer, 9mm (H), 22mm (L), 6° Lordosis |
| 00846468084547 | Fortilink-TS IBF System Trial Spacer, 8mm (H), 22mm (L), 6° Lordosis |
| 00846468084530 | Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L) |
| 00846468084523 | Fortilink-TS IBF System Trial Spacer, 16mm (H), 22mm (L) |
| 00846468084516 | Fortilink-TS IBF System Trial Spacer, 15mm (H), 22mm (L) |
| 00846468084509 | Fortilink-TS IBF System Trial Spacer, 14mm (H), 22mm (L) |
| 00846468084493 | Fortilink-TS IBF System Trial Spacer, 13mm (H), 22mm (L) |
| 00846468084486 | Fortilink-TS IBF System Trial Spacer, 12mm (H), 22mm (L) |
| 00846468084479 | Fortilink-TS IBF System Trial Spacer, 11mm (H), 22mm (L) |
| 00846468084462 | Fortilink-TS IBF System Trial Spacer, 10mm (H), 22mm (L) |
| 00846468084455 | Fortilink-TS IBF System Trial Spacer, 9mm (H), 22mm (L) |
| 00846468084448 | Fortilink-TS IBF System Trial Spacer, 8mm (H), 22mm (L) |