Medline Industries, Inc.
Spng NEURO.75X.75 XR 10/PK
2manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | HBA |
| Device type | Neurosurgical Paddie |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4700 |
| 510(k) | K193346 |
| Record published | 2024-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJZ17617 | In distribution | |
| DYNJZ155353 | In distribution | |
| DYNJZ150567 | In distribution | |
| DYNJZ17616 | In distribution | |
| DYNJZJJ801402 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OMT LLC | OMT, LLC | 126 |
| Neuray ® | Medtronic Xomed, Inc. | 63 |
| Codman® | Integra LifeSciences Production Corporation | 42 |
| Codman | Cerenovus, Inc. | 41 |
| Americot | American Surgical Company, LLC | 39 |
| Spetzler Neuro Patties | OMT, LLC | 35 |
| Merocel | Medtronic Xomed, Inc. | 34 |
| Ray-Cot | American Surgical Company, LLC | 26 |
| Uniqcot | American Surgical Company, LLC | 24 |
| Medline | Medline Industries, Inc. | 19 |
| Zevo™ Anterior Cervical Plate System | Medtronic Sofamor Danek, Inc. | 17 |
| Ultracot | American Surgical Company, LLC | 15 |
Showing 12 of 24. All products under Neurosurgical Paddie
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140369 | 2014-09-26 |
Recalls Naming This Product
23 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 1791 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 2615 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 2894 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 21553 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 168803 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 33478 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 80515 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 44231 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 69179 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 56082 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 201914 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 93782 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 9563 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 826 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 6706 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 4818 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 10719 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 2056 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 1222 |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 1454 units |
| Integra Lifesciences Corporation | 510(k) number | 2024-09-20 | Class II | Nonconforming Material/Component | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods | 3494 units |
| Integra Lifesciences Corporation | 510(k) number | 2022-12-02 | Class II | Process control | Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever. | 168 US; 3 OUS |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.