FDA Registration
Active
🇺🇸 United States
Poly Tibial Trial - Size 44x9mm-F - 300072
Reg #: 3006108336
·
FEI: 3006108336
·
Expires 2025
Products
1
Proprietary Names
196
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CAYENNE MEDICAL, INC.
- Registration Number
- 3006108336
- FEI Number
- 3006108336
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 16597 N. 92ND STREET, SUITE 101
- City
- SCOTTSDALE
- State
- AZ
- ZIP
- 85260
- Country
- US
Owner / Operator
- Firm Name
- CAYENNE MEDICAL, INC.
- Operator Number
- 9091610
- Address
- 16597 N. 92ND STREET, SUITE 101
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85260
- Country
- US
- Correspondent
- Jessica - Rose
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Template | HWT | Class 1 | Orthopedic | No | 2014-12-24 |
Proprietary Names
Poly Tibial Trial - Size 44x9mm-F - 300072
Mirror Tibial Guide, Right Size 44 + 1mm Offset - 300394
Mirror Tibial Guide, Left Size 48 - 1mm Offset - 300461
Mirror Planer Base - Large - 300532
Mirror TRG - EM Rod Lower - 300342
Poly Tibial Trial - Size 48x10mm-F - 300078
Mirror Cutter Shim - Size 2 - 300166
Mirror Positioner - Small LM - 300527
Poly Tibial Trial - Size 48x11mm-F - 300079
Mirror Femoral Template - Size 54 - 300295
Mirror Tibial Shim Plate - 56mm - 9mm - 300451
Mirror Femoral Positioning Guides - Size 50 RM - 300520
Mirror Anchor Pin - 300120
Mirror MODULAR TIBIA TRIAL INSERT (56 x 8MM) - 300374
Mirror Modular Tibia Trial Baseplate RM/LL-52mm - 300389
Mirror Femoral Template - Size 38 - 300291
Mirror MODULAR TIBIA TRIAL INSERT (44 x 11MM) - 300365
Poly Tibial Trial - Size 56x9mm-F - 300087
Mirror SFC - 4 - LEFT - 300266
Mirror Tibial Inserter - 300253
Mirror Tibial Guide, Right Size 56 + 2mm Offset - 300406
Mirror Tibial Guide - R48 - 300331
Mirror Tibial Shim Plate - 56mm - 11mm - 300453
Mirror Femoral Template Spacer - 5/6mm - 300412
Mirror Tibial Shim Plate - 52mm - 9mm - 300447
Mirror IntraCap® SFC - large - 300512
Mirror MODULAR TIBIA TRIAL INSERT (48 x 10MM) - 300368
Mirror MODULAR TIBIA TRIAL INSERT (52 x 9MM) - 300371
Mirror TRG Stylus - 300356
Mirror DP Shim - 9 mm - 300507
Mirror Positioner - Large RM - 300530
Mirror TRG -Ankle Clamp - 300341
Mirror Tibial Guide - L52 - 300334
Mirror Tibial Shim Plate - 56mm - 10mm - 300452
AperFix Tibial Guide Arch - CM-7321
Mirror Tibial Guide, Right Size 52 - 1mm Offset - 300464
Poly Tibial Trial - Size 52x11mm-F - 300084
Mirror Femoral Template - Size 46 - 300293
Mirror Tibial Punch - 300459
Poly Tibial Trial - Size 56x10mm-F - 300088
Mirror MODULAR TIBIA TRIAL INSERT (56 x 9MM) - 300375
Poly Tibial Trial - Size 48x9mm-F - 300077
Mirror Cutter Shim - Size 3 - 300167
Mirror Tibial Shim Plate - 52mm - 11mm - 300449
Mirror Planer Guide - Large - 300534
AperFix Tendon Sizing Block, 6-12mm - CM-1612
AperFix Tibial Guide Arm, Point-to-Point - CM-7323
Mirror Positioner - Small RM - 300528
Mirror Femoral Positioning Guides - Size 38 RM - 300514
Poly Tibial Trial - Size 52x10mm-F - 300083
Mirror Femoral Inserter - 300263
Mirror Tibial Shim Plate - 44mm - 8mm - 300438
AperFix Femoral Guide, 6mm - CM-7260
Mirror Femoral Positioning Guides - Size 54 LM - 300521
Poly Tibial Trial - Size 56x8mm-F - 300086
Mirror MODULAR TIBIA TRIAL INSERT (48 x 8MM) - 300366
Mirror MODULAR TIBIA TRIAL INSERT (48 x 9MM) - 300367
Mirror Tibial Guide - R52 - 300333
Mirror Sweep Cutter - Lg - 300179
Mirror Tibial Guide, Right Size 48 + 2mm Offset - 300404
Mirror Tibial Shim Plate - 44mm - 11mm - 300441
Mirror Tibial Guide, Right Size 48 - 2mm Offset - 300462
Mirror Tibial Guide, Right Size 52 + 1mm Offset - 300396
Mirror Tibial Guide, Right Size 56 - 2mm Offset - 300470
Poly Tibial Trial - Size 56x11mm-F - 300089
Mirror Femoral Two Post Trial - Size 42mm - 300489
Mirror MODULAR TIBIA TRIAL INSERT (56 x 10MM) - 300376
Mirror Tibial Shim Plate - 44mm - 9mm - 300439
Mirror Femoral Two Post Alignment Pin - 300502
Mirror Cutter Shim - Size 1 - 300165
Mirror TRG - Resection (Cutter) Block - Left - 300345
Mirror Femoral Positioning Guides - Size 50 LM - 300519
Mirror MODULAR TIBIA TRIAL INSERT (52 x 11MM) - 300373
Mirror Femoral Two Post Trial - Size 46mm - 300490
Mirror Femoral Two Post Trial - Size 54mm - 300492
Poly Tibial Trial - Size 48x8mm-F - 300076
Mirror Femoral Template - Size 50 - 300294
Mirror Femoral Positioning Guides - Size 42 LM - 300515
Mirror Tibial Guide - R56 - 300335
Mirror Tibial Guide, Left Size 56 + 1mm Offset - 300402
Mirror Tibial Guide, Left Size 52 - 1mm Offset - 300465
Mirror Planer Guide - Small - 300533
Mirror SFC - 4 - RIGHT - 300265
Mirror TRG - Resection (Cutter) Block - Right - 300344
Mirror Tibial Guide, Left Size 44 + 1mm Offset - 300399
Mirror Tibial Shim Plate - 56mm - 8mm - 300450
Mirror IntraCap® SFC - Small - 300511
Mirror MODULAR TIBIA TRIAL INSERT (48 x 11MM) - 300369
Mirror Modular Tibia Trial Baseplate RM/LL-44mm - 300385
Mirror Poly Tibial Trial - Size 44x8mm - F - 300071
Mirror Femoral Template - Size 42 - 300292
Mirror MODULAR TIBIA TRIAL INSERT (44 x 10MM) - 300364
Mirror Modular Tibia Trial Baseplate RM/LL-48mm - 300387
AperFix Tibial Guide Arm, Point-to-Elbow - CM-7324
AperFix Tibial Guide Bullet - CM-7322
Mirror Cutter Shim - Size 4 - 300168
Mirror Tibial Shim Plate - 52mm - 10mm - 300448
Poly Tibial Trial - Size 44x10mm-F - 300073
Mirror Angled Cutter - Small Right - 300273
Mirror Tibial Shim Plate - 48mm - 8mm - 300442
Mirror Tibial Guide - Left Size 56 - 2mm Offset - 300471
Mirror Sweep Cutter - Sm - 300180
Mirror Tibial Guide - R44 - 300329
Mirror Modular Tibial Inserter - 300429
Mirror Tibial Guide, Left Size 52 - 2mm Offset - 300467
Mirror Modular Tibia Trial Baseplate LM/RL-56mm - 300390
Mirror Modular Tibia Trial Baseplate RM/LL-56mm - 300391
Poly Tibial Trial - Size 44x11mm-F - 300074
Mirror Modular Tibia Trial Baseplate LM/RL-44mm - 300384
Mirror Femoral Positioning Guides - Size 54 RM - 300522
Mirror Angled Cutter - Small Left - 300274
Mirror Femoral Template Spacer - 7/8mm - 300413
Mirror Tibial Guide, Left Size 56 - 1mm Offset - 300469
Mirror SFC - 1 - RIGHT - 300271
Mirror Tibial Guide, Right Size 56 + 1mm Offset - 300397
Mirror TRG - EM Rod Upper - 300458
Mirror Tibial Guide - L48 - 300332
Mirror Tibial Guide, Left Size 48 + 2mm Offset - 300408
Mirror DP Shim - 10 mm - 300508
Mirror Femoral Positioning Guides - Size 46 LM - 300517
Mirror Modular Tibia Trial Baseplate LM/RL-52mm - 300388
Mirror Modular Tibia Trial Baseplate LM/RL-48mm - 300386
Mirro Tibial Guide - L56 - 300336
Mirror Tibial Guide, Left Size 52 + 2mm Offset - 300409
Mirror Tibial Guide, Right Size 44 - 1mm Offset - 300476
Mirror Planer Base - Small - 300531
Mirror Tibial Guide - L44 - 300330
Mirror Tibial Guide, Right Size 48 + 1mm Offset - 300395
Mirror DP Shim - 8 mm - 300506
Mirror Femoral Positioning Guides - Size 46 RM - 300518
Mirror MODULAR TIBIA TRIAL INSERT (52 x 10MM) - 300372
Mirror Femoral Two Post Trial - Size 38mm - 300488
Mirror MODULAR TIBIA TRIAL INSERT (56 x 11MM) - 300377
Mirror Primary Cutter Guard - 300309
Mirror Tibial Guide, Right Size 52 + 2mm Offset - 300405
Mirror Tibial Shim Plate - 52mm - 8mm - 300446
Mirror SFC - 2 - RIGHT - 300269
Mirror TRG - Depth Guide - 3 mm - 300346
Mirror Tibial Guide - Left Size 56 + 2mm Offset - 300410
Mirror Tibial Shim Plate - 48mm - 11mm - 300445
Mirror Tibial Guide, Left Size 44 - 1mm Offset - 300477
Mirror Femoral Template Spacer - 9/10mm - 300414
Mirror DP Shim - 11 mm - 300509
Mirror Positioner - Large LM - 300529
Mirror MODULAR TIBIA TRIAL INSERT (44 x 9MM) - 300363
Mirror Tibial Shim Plate - 48mm - 9mm - 300443
Mirror Tibial Guide, Left Size 48 - 2mm Offset - 300463
AperFix Femoral Guide, 7mm - CM-7270
Poly Tibial Trial - Size 52x8mm-F - 300081
Mirror MODULAR TIBIA TRIAL INSERT (52 x 8MM) - 300370
Mirror SFC - 2 - LEFT - 300270
Mirror Tibial Guide, Left Size 52 + 1mm Offset - 300401
Mirror Tibial Shim Plate - 44mm - 10mm - 300440
Mirror Tibial Guide, Right Size 56 - 1mm Offset - 300468
Mirror Tibial Guide, Right Size 48 - 1mm Offset - 300460
Mirror Femoral Positioning Guides - Size 42 RM - 300516
Mirror MODULAR TIBIA TRIAL INSERT (44 x 8MM) - 300362
Mirror Femoral Two Post Trial - Size 50mm - 300491
Mirror SFC - 1 - LEFT - 300272
Mirror TRG - Depth Guide - 5 mm - 300347
Mirror Tibial Guide, Left Size 48 + 1mm Offset - 300400
Mirror Tibial Shim Plate - 48mm - 10mm - 300444
Mirror Tibial Guide, Right Size 52 - 2mm Offset - 300466
Tibial Punch Plate - Size 56 - 300594
AperFix Femoral Guide, 5.5mm - CM-7255
Poly Tibial Trial - Size 52x9mm-F - 300082
Mirror Femoral Positioning Guides - Size 38 LM - 300513
TRG - Lower Slide - 300582
Tibial Punch Plate Gage - Right - 300601
EM Lower Rod - Bottom Knob - 300587
TGP - Shim - 9 mm - 300565
Alignment Rod - 300620
TDG - Base - 300583
Planer Handle - 300602
Tibial Punch Plate - Size 44 - 300591
TRG - EM Tower - Left - 300577
TRG - EM Tower - Right - 300578
TRG - EM Upper Rod - Short - 300579
Adjustable Guide - Small - 300595
TRG - Cutting Block - Left - 300575
TRG - EM Upper Rod - Long - 300580
Adjustable Guide - Large - 300596
Tibial Punch Plate - Size 48 - 300592
TDG - ARM - 3/5 mm - 300585
TDG - ARM - 2/4 mm - 300584
Tibial Spacer 8/9 - 300617
TRG - EM Lower Rod - 300581
Tibial Punch Plate Gage - Left - 300600
Lower Slide - Knob - 300588
TGP - Shim - 8 mm - 300564
Tibial Spacer 10/11 - 300618
TGP - Shim - 11 mm - 300567
Tibial Punch Plate - Size 52 - 300593
TDG - Locking Knob - 300586
TRG - Cutting Block - Right - 300576
TGP - Shim - 10 mm - 300566
Establishment Types
Manufacture Medical Device