ORTHOLOC™ SPS
GUDID 00846832073573
TORNIER, INC.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 00846832073573 |
| NIH Device Record Key | f91d4d8d-1c18-4da4-b78e-c12800140c90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOLOC™ SPS |
| Version Model Number | SPS336 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| 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 | false |
| Expiration Date | false |
| 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
| Length | 36 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 36 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832073573 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181587
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
[00846832073573]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-14 |
| Device Publish Date | 2018-12-14 |
On-Brand Devices [ORTHOLOC™ SPS]
Trademark Results [ORTHOLOC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOLOC 77636931 4222143 Live/Registered |
Wright Medical Technology, Inc. 2008-12-19 |
 ORTHOLOC 73596966 1417357 Live/Registered |
DOW CORNING CORPORATION 1986-05-05 |
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