ExoShape 1600-00-011
GUDID 20845854082161
EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 11MM x 21 MM
Conmed Corporation
Tendon/ligament bone anchor, non-bioabsorbable| Primary Device ID | 20845854082161 |
| NIH Device Record Key | a333f871-c20f-44a9-ad15-8fbde32dddce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ExoShape |
| Version Model Number | 1600-00-011 |
| Catalog Number | 1600-00-011 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20845854082161 [Primary] |
| GS1 | 30845854082168 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132783
FDA Product Code
| HWC | Screw, fixation, bone |
| MBI | Fastener, fixation, nondegradable, soft tissue |
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 | 2020-09-30 |
| Device Publish Date | 2020-09-22 |
On-Brand Devices [ExoShape]
| 20845854082161 | EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 11MM x 21 MM |
| 30845854082168 | EXOSHAPE SOFT TISSUE FASTENER FEMORAL 11 MM |
| 30845854082151 | EXOSHAPE SOFT TISSUE FASTENER FEMORAL 10 MM |
| 30845854082144 | EXOSHAPE SOFT TISSUE FASTENER FEMORAL 9 MM |
| 30845854082137 | EXOSHAPE SOFT TISSUE FASTENER FEMORAL 8 MM |
| 20653405986888 | EXOSHAPE SOFT TISSUE FASTENER TIBIAL, 12 MM x 30 MM |
| 20653405986871 | EXOSHAPE SOFT TISSUE FASTENER TIBIAL, 11 MM x 30 MM |
| 20653405986864 | EXOSHAPE SOFT TISSUE FASTENER TIBIAL, 10 MM x 30 MM |
| 20653405986857 | EXOSHAPE SOFT TISSUE FASTENER TIBIAL, 9 MM x 30 MM |
| 20653405986840 | EXOSHAPE SOFT TISSUE FASTENER TIBIAL, 8 MM x 30 MM |
| 20653405986833 | EXOSHAPE SOFT TISSUE FASTENER TIBIAL, 7 MM x 30 MM |
| 30653405987141 | ExoShape Sheath Inserter 10 mm |
| 30653405987042 | ExoShape Removal Tool Femoral |
| 30653405987035 | ExoShape Instrument Caddy |
| 10653405987024 | ExoShape Gun Tibial |
| 30653405987011 | ExoShape Removal Tool Tibial |
| 30653405987004 | ExoShape Graft Bar |
| 30653405986991 | ExoShape Sheath Inserter 12 mm |
| 30653405986984 | ExoShape Sheath Inserter 11 mm |
| 10653405986973 | ExoShape Sheath Inserter 9 mm |
| 10653405986966 | ExoShape Sheath Inserter 8 mm |
| 10653405986959 | ExoShape Sheath Inserter 7 mm |
| 30653405986946 | ExoShape Trialator 11 mm |
| 30653405986939 | ExoShape Trialator 10 mm |
| 10653405986928 | ExoShape Trialator 9 mm |
| 30653405986915 | ExoShape Trialator 8 mm |
| 30653405986908 | ExoShape Trialator 7 mm |
| 10653405986898 | ExoShape Trialator 6 mm |
Trademark Results [ExoShape]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXOSHAPE 85125012 3982761 Live/Registered |
CONMED CORPORATION 2010-09-08 |
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