| Primary Device ID | 00195860012413 |
| NIH Device Record Key | 3e245e9f-9cc4-4010-a726-104368492f23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Whistler Modular Pedicle Screw System |
| Version Model Number | EV-09-CD1-CANNLUATED |
| Catalog Number | EV-09-CD1-CANNLUATED |
| Company DUNS | 116940934 |
| Company Name | Evolution Spine LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com | |
| Phone | +1(214)682-8536 |
| info@evolutionspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195860012413 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
[00195860012413]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-25 |
| Device Publish Date | 2021-05-17 |
| 00195860000045 | Locking Cap, Solid, 6.0mm |
| 00195860000038 | Locking Cap, Cannulated, 6.0 mm |
| 00195860000021 | Locking Cap, Solid |
| 00195860000014 | Locking Cap, Cannulated |
| 00195860004579 | DIA 10.5 x 75mm, Solid, HA |
| 00195860004432 | DIA 10.5 x 75mm, Solid |
| 00195860004296 | DIA 9.5 x 75mm, Solid, HA |
| 00195860004159 | DIA 9.5 x 75mm, Solid |
| 00195860012239 | MIS Locking Cap Starter |
| 00195860012222 | Tulip Inserter Forceps |
| 00195860012567 | MIS Rod Caddy + Lid |
| 00195860012550 | Open Rod Caddy + Lid |
| 00195860012543 | Screw Caddy Lid |
| 00195860012536 | 10.5mm Screw Caddy |
| 00195860012529 | 9.5mm Screw Caddy |
| 00195860012512 | 8.5mm Screw Caddy |
| 00195860012505 | 8.0mm Screw Caddy |
| 00195860012499 | 7.5mm Screw Caddy |
| 00195860012482 | 7.0mm Screw Caddy |
| 00195860012475 | 6.5mm Screw Caddy |
| 00195860012468 | 6.0mm Screw Caddy |
| 00195860012451 | 5.5mm Screw Caddy |
| 00195860012444 | 4.75mm Screw Caddy |
| 00195860012437 | Tulip Caddy + Lid |
| 00195860012420 | Solid Locking Cap Caddy + Lid |
| 00195860012413 | Cannulated Locking Cap Caddy + Lid |
| 00195860012406 | Rod Caddy + Lid |
| 00195860012390 | Implant Case Lid |
| 00195860012383 | Implant Case |
| 00195860012376 | MODULAR REDUCTION TULIP INSERTER, THD, 8 INCH |
| 00195860012369 | ROD ROCKER ASSEMBLY, LONG |
| 00195860012352 | Screw Gauge |
| 00195860012345 | FINAL TIGHTENING DRIVER, 8.5 INCH |
| 00195860012338 | MIS ROD INSERTER |
| 00195860005453 | Whistler Instrument Case 3 Tray 2 |
| 00195860005446 | Whistler Instrument Case 3 Tray 1 |
| 00195860005439 | Whistler Instrument Case 3 Lid |
| 00195860005422 | Whistler Instrument Case 2 Tray 2 |
| 00195860005415 | Whistler Instrument Case 2 Tray 1 |
| 00195860005408 | Whistler Instrument Case 2 Lid |
| 00195860005392 | Whistler Instrument Case 1 Tray 2 |
| 00195860005385 | Whistler Instrument Case 1 Tray 1 |
| 00195860005378 | Whistler Instrument Case 1 Lid |
| 00195860005361 | Rod Gripper |
| 00195860005354 | Ratcheting T-Handle |
| 00195860005347 | Compressor |
| 00195860005330 | Distractor |
| 00195860005323 | 5.5mm Double Action Gripper |
| 00195860005316 | Straight Ratcheting Handle |
| 00195860005309 | Flexible Rod Template |