OrthoMedFlex 111-16-0120
GUDID M7161111601200
Cement Plug, Size 17mm, LLDPE
ORTHOMEDFLEX LLC
Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile| Primary Device ID | M7161111601200 |
| NIH Device Record Key | 8a4193ea-495f-4f9f-9ed7-d48b156d393c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoMedFlex |
| Version Model Number | 111160120 |
| Catalog Number | 111-16-0120 |
| Company DUNS | 034442726 |
| Company Name | ORTHOMEDFLEX LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7161111601200 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121297
FDA Product Code
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-03 |
| Device Publish Date | 2020-08-26 |
On-Brand Devices [OrthoMedFlex]
| M7161121525260 | Trial Liner 20° 36/60-70 (E) |
| M7161121525250 | Trial Liner 20° 36/56-58 (D) |
| M7161121525240 | Trial Liner 20° 36/52-54 (C) |
| M7161121525230 | Trial Liner 20° 32/60-70 (E) |
| M7161121525220 | Trial Liner 20° 32/56-58 (D) |
| M7161121525210 | Trial Liner 20° 32/52-54 (C) |
| M7161121525200 | Trial Liner 20° 32/48-50 (B) |
| M7161121525190 | Trial Liner 20° 28/52-54 (C) |
| M7161121525180 | Trial Liner 20° 28/48-50 (B) |
| M7161121525170 | Trial Liner 20° 28/44-46 (A) |
| M7161121525160 | Trial Liner 20° 22/40-42 |
| M7161121588520 | Trial Liner, 28/52-54C (+4 10° Hooded Lateralised) |
| M7161121588500 | Trial Liner, 28/48-50B (+4 10° Hooded Lateralised) |
| M7161121588440 | Trial Liner, 28/44-46A (+4 10° Hooded Lateralised) |
| M7161121586600 | Trial Liner, 36/60-68E (+4 10° Hooded Lateralised) |
| M7161121586560 | Trial Liner, 36/56-58D (+4 10° Hooded Lateralised) |
| M7161121586520 | Trial Liner, 36/52-54C (+4 10° Hooded Lateralised) |
| M7161121582600 | Trial Liner, 32/60-68E (+4 10° Hooded Lateralised) |
| M7161121582560 | Trial Liner, 32/56-58D (+4 10° Hooded Lateralised) |
| M7161121582520 | Trial Liner, 32/52-54C (+4 10° Hooded Lateralised) |
| M7161121582500 | Trial Liner, 32/48-50B (+4 10° Hooded Lateralised) |
| M7161121582400 | Trial Liner, 22/40-42 (+4 10° Hooded Lateralised) |
| M7161121578520 | Trial Liner, 28/52-54C (+4 Neutral Lateralised) |
| M7161121578500 | Trial Liner, 28/48-50B (+4 Neutral Lateralised) |
| M7161121578440 | Trial Liner, 28/44-46A (+4 Neutral Lateralised) |
| M7161121576600 | Trial Liner, 36/60-68E (+4 Neutral Lateralised) |
| M7161121576560 | Trial Liner, 36/56-58D (+4 Neutral Lateralised) |
| M7161121576520 | Trial Liner, 36/52-54C (+4 Neutral Lateralised) |
| M7161121572600 | Trial Liner, 32/60-68E (+4 Neutral Lateralised) |
| M7161121572560 | Trial Liner, 32/56-58D (+4 Neutral Lateralised) |
| M7161121572520 | Trial Liner, 32/52-54C (+4 Neutral Lateralised) |
| M7161121572500 | Trial Liner, 32/48-50B (+4 Neutral Lateralised) |
| M7161121572400 | Trial Liner, 22/40-42 (+4 Neutral Lateralised) |
| M7161122500790 | Femoral Head Extractor Long |
| M7161122500380 | Femoral Head Extractor |
| M7161122401010 | Bipolar Head Inserter |
| M716101144010 | Thread Adaptor |
| M7161011410 | Femoral Head Extractor |
| M716AL2361560 | Tryon Acetabular Cup Liner, Neutral, SIZE 36/56-58mm XL - UHMWPE |
| M716AFS65200 | Tryon Acetabular Bone Screw, SIZE 20mm Ti6AI4V Alloys |
| M7161111243680 | 68mm Acetabular Cup (3-Hole) HA |
| M7161111243660 | 66mm Acetabular Cup (3-Hole) HA |
| M7161111243640 | 64mm Acetabular Cup (3-Hole) HA |
| M7161111243620 | 62mm Acetabular Cup (3-Hole) HA |
| M7161111243600 | 60mm Acetabular Cup (3-Hole) HA |
| M7161111243580 | 58mm Acetabular Cup (3-Hole) HA |
| M7161111243560 | 56mm Acetabular Cup (3-Hole) HA |
| M7161111243540 | 54mm Acetabular Cup (3-Hole) HA |
| M7161111243520 | 52mm Acetabular Cup (3-Hole) HA |
| M7161111243500 | 50mm Acetabular Cup (3-Hole) HA |
Trademark Results [OrthoMedFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOMEDFLEX 86216632 4886418 Live/Registered |
Orthomedflex, LLC 2014-03-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.