POPLOK GKP-3301
GUDID 20845854014285
3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE
Conmed Corporation
Tendon/ligament bone anchor, non-bioabsorbable| Primary Device ID | 20845854014285 |
| NIH Device Record Key | 7fd042e8-1ef9-408e-905d-8249168c0636 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POPLOK |
| Version Model Number | GKP-3301 |
| Catalog Number | GKP-3301 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
| Outer Diameter | 3.3 Millimeter |
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 |
| 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 | 10845854014288 [Package] Package: Carton [1 Units] In Commercial Distribution |
| GS1 | 20845854014285 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091549
FDA Product Code
| MBI | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [POPLOK]
| 20845854014285 | 3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE |
| 20845854014124 | 4.5MM POPLOK SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES |
| 20845854014117 | 2.8MM SRS POPLOK SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE |
| 20845854014100 | 4.5MM POPLOK SUTURE ANCHOR |
| 20845854013998 | 3.3MM SRS POPLOK, SUTURE ANCHOR WITH TWO NO. 0 (3.5 METRIC) HI-FI SUTURES |
| 20845854013851 | 3.5MM SRS POPLOK SUTURE ANCHOR |
| 20845854013714 | 3.5MM POPLOK SUTURE ANCHOR WITH ONE NO. 2, (5 METRIC) HI-FI SUTURE |
| 20845854013554 | 2.8MM SRS POPLOK, SUTURE ANCHOR WITH TWO NO. 0 (3.5 METRIC) HI-FI SUTURES |
| 20845854030353 | 2.8MM POPLOK DRILL BIT |
| 20845854030346 | POPLOK DRILL GUIDE |
| 20845854028282 | POPLOK PUNCH 4.5MM |
| 20845854028275 | POPLOK PUNCH 3.5MM |
| 10845854030370 | POPLOK OBTURATOR |
| 10845854028292 | PopLok Punch with Depth Stop |
Trademark Results [POPLOK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POPLOK 77740905 3770304 Live/Registered |
PAX IP INC. 2009-05-20 |
 POPLOK 77717288 3880771 Live/Registered |
CONMED CORPORATION 2009-04-20 |
 POPLOK 74579586 1954480 Dead/Cancelled |
Gianni Enterprises, Inc. 1994-09-28 |
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