Perla ® TL MIS
Modular Cannulated Fenestrated Polyaxial Bone Screw
11manufacturers in China registered for this device type
495catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Spineart SA, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2022-02-08 |
| Record revised | 2025-03-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 1.6 to 10.5 mm; length 25 to 525 mm; angle 90 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MPF-SS 75 45-S | Outer Diameter 7.5 mm | In distribution |
| MPF-SS 55 35-S | Outer Diameter 5.5 mm | In distribution |
| MPF-SX 55 45-N | Length 45 mm | In distribution |
| MPF-ST 62 50-N | Length 250 mm | In distribution |
| MPF-ST 61 30-S | Length 130 mm | In distribution |
| MPF-PS 85 10-S | Outer Diameter 8.5 mm | In distribution |
| MPF-ST 52 00-S | Length 200 mm | In distribution |
| MPF-ST 62 10-S | Length 210 mm | In distribution |
| MPF-SS 55 30-S | Outer Diameter 5.5 mm | In distribution |
| MPF-ST 60 75-N | Length 75 mm | In distribution |
| MPF-ST 51 80-S | Length 180 mm | In distribution |
| MPF-ST 61 70-N | Length 170 mm | In distribution |
| MPF-SX 45 25-N | Length 25 mm | In distribution |
| MPF-SX 85 40-N | Length 40 mm | In distribution |
| MPF-ST 61 00-S | Length 100 mm | In distribution |
| MPF-SS 65 30-S | Outer Diameter 6.5 mm | In distribution |
| MPF-SX 75 45-N | Length 45 mm | In distribution |
| MPF-SS 85 35-N | Length 35 mm | In distribution |
| MPF-IN 20 00-N | In distribution | |
| MPF-ST 52 30-S | Length 230 mm | In distribution |
| MPF-SX 65 60-N | Length 60 mm | In distribution |
| MPF-ST 62 30-N | Length 230 mm | In distribution |
| MPF-SS 75 35-N | Length 35 mm | In distribution |
| MPF-PS 65 50-S | Length 50 mm | In distribution |
| MPF-BT 50 80-S | Length 80 mm | In distribution |
| MPF-PS 95 12-S | Outer Diameter 9.5 mm | In distribution |
| MPF-PS 15 12-S | Outer Diameter 10.5 mm | In distribution |
| MPF-IN 01 00-N | In distribution | |
| MPF-IN 27 00-N | In distribution | |
| MPF-PS 85 35-S | Outer Diameter 8.5 mm | In distribution |
| MPF-SS 85 50-N | Length 50 mm | In distribution |
| MPF-PS 85 80-S | Outer Diameter 8.5 mm | In distribution |
| MPF-ST 50 30-S | Length 30 mm | In distribution |
| MPF-PS 55 50-S | Length 50 mm | In distribution |
| MPF-BS 45 30-S | Length 30 mm | In distribution |
| MPF-PS 85 40-S | Outer Diameter 8.5 mm | In distribution |
| MPF-SS 85 30-S | Outer Diameter 8.5 mm | In distribution |
| MPF-IN 04 02-N | In distribution | |
| MPF-IN 13 00-N | In distribution | |
| MPF-SX 65 40-S | Outer Diameter 6.5 mm | In distribution |
| MPF-SX 75 55-N | Length 55 mm | In distribution |
| MPF-IN 30 00-N | In distribution | |
| MPF-SX 45 40-N | Length 40 mm | In distribution |
| MPF-IN 05 01-N | In distribution | |
| MPF-PX 55 50-S | Outer Diameter 5.5 mm | In distribution |
| MPF-PS 85 12-S | Outer Diameter 8.5 mm | In distribution |
| MPF-BS 55 40-S | Length 40 mm | In distribution |
| MPF-ST 51 10-N | Length 110 mm | In distribution |
| MPF-SS 45 25-N | Length 25 mm | In distribution |
| MPF-SS 55 45-N | Length 45 mm | In distribution |
| MPF-PS 75 90-S | Outer Diameter 7.5 mm | In distribution |
| MPF-ST 61 80-S | Length 180 mm | In distribution |
| MPF-BS 75 30-S | Length 30 mm | In distribution |
| MPF-SX 85 50-N | Length 50 mm | In distribution |
| MPF-ST 51 30-S | Length 130 mm | In distribution |
| MPF-SX 45 35-S | Outer Diameter 4.5 mm | In distribution |
| MPF-IN 10 00-N | In distribution | |
| MPF-ST 61 30-N | Length 130 mm | In distribution |
| MPF-BT 50 35-N | Length 35 mm | In distribution |
| MPF-BX 02 10-N | In distribution | |
| MPF-BS 75 55-S | Length 55 mm | In distribution |
| MPF-BS 15 10-S | Outer Diameter 10.5 mm | In distribution |
| MPF-ST 50 65-N | Length 65 mm | In distribution |
| MPF-BT 60 70-S | Length 70 mm | In distribution |
| MPF-IN 04 01-N | In distribution | |
| MPF-SS 75 30-N | Length 30 mm | In distribution |
| MPF-SX 85 45-N | Length 45 mm | In distribution |
| MPF-SX 45 30-N | Length 30 mm | In distribution |
| MPF-PS 85 60-S | Outer Diameter 8.5 mm | In distribution |
| MPF-PX 45 40-S | Outer Diameter 4.5 mm | In distribution |
| MPF-SX 55 30-S | Outer Diameter 5.5 mm | In distribution |
| MPF-PX 85 60-S | Outer Diameter 8.5 mm | In distribution |
| MPF-SS 55 45-S | Outer Diameter 5.5 mm | In distribution |
| MPF-BS 95 70-S | Outer Diameter 9.5 mm | In distribution |
| MPF-BS 55 60-S | Length 60 mm | In distribution |
| MPF-PS 95 11-S | Outer Diameter 9.5 mm | In distribution |
| MPF-SS 55 40-S | Outer Diameter 5.5 mm | In distribution |
| MPF-SS 75 55-S | Outer Diameter 7.5 mm | In distribution |
| MPF-BS 65 30-S | Length 30 mm | In distribution |
| MPF-SX 55 40-N | Length 40 mm | In distribution |
| MPF-BT 50 60-S | Length 60 mm | In distribution |
| MPF-PX 55 25-S | Outer Diameter 5.5 mm | In distribution |
| MPF-PX 65 50-S | Outer Diameter 6.5 mm | In distribution |
| MPF-BT 60 75-S | Length 75 mm | In distribution |
| MPF-SS 65 55-S | Outer Diameter 6.5 mm | In distribution |
| MPF-BT 60 35-S | Length 35 mm | In distribution |
| MPF-ST 52 40-N | Length 240 mm | In distribution |
| MPF-PX 85 35-S | Outer Diameter 8.5 mm | In distribution |
| MPF-BS 85 90-S | Outer Diameter 8.5 mm | In distribution |
| MPF-PS 45 25-S | Length 25 mm | In distribution |
| MPF-SX 85 40-S | Outer Diameter 8.5 mm | In distribution |
| MPF-IN 16 50-N | Outer Diameter 5 mm | In distribution |
| MPF-SS 85 40-S | Outer Diameter 8.5 mm | In distribution |
| MPF-ST 60 50-S | Length 50 mm | In distribution |
| MPF-ST 52 10-N | Length 210 mm | In distribution |
| MPF-PS 95 80-S | Outer Diameter 9.5 mm | In distribution |
| MPF-ST 60 30-N | Length 30 mm | In distribution |
| MPF-SX 75 50-S | Outer Diameter 7.5 mm | In distribution |
| MPF-SS 65 25-S | Outer Diameter 6.5 mm | In distribution |
| MPF-BS 15 70-S | Outer Diameter 10.5 mm | In distribution |
| MPF-PS 75 70-S | Outer Diameter 7.5 mm | In distribution |
| MPF-SX 85 60-S | Length 60 mm | In distribution |
| MPF-SX 65 55-N | Length 55 mm | In distribution |
| MPF-BS 85 11-S | Outer Diameter 8.5 mm | In distribution |
| MPF-SS 65 45-S | Outer Diameter 6.5 mm | In distribution |
| MPF-IN 15 01-N | In distribution | |
| MPF-PS 55 25-S | Length 25 mm | In distribution |
| MPF-BS 75 40-S | Length 40 mm | In distribution |
| MPF-ST 51 00-S | Length 100 mm | In distribution |
| MPF-ST 50 50-N | Length 50 mm | In distribution |
| MPF-SS 45 45-N | Length 45 mm | In distribution |
| MPF-PS 65 30-S | Length 30 mm | In distribution |
| MPF-ST 60 80-N | Length 80 mm | In distribution |
| MPF-SX 55 25-S | Outer Diameter 5.5 mm | In distribution |
| MPF-PS 75 12-S | Outer Diameter 7.5 mm | In distribution |
| MPF-PX 55 35-S | Outer Diameter 5.5 mm | In distribution |
| MPF-SX 65 40-N | Length 40 mm | In distribution |
| MPF-PS 45 30-S | Length 30 mm | In distribution |
| MPF-SX 75 50-N | Length 50 mm | In distribution |
| MPF-SX 65 25-N | Length 25 mm | In distribution |
| MPF-PS 85 11-S | Outer Diameter 8.5 mm | In distribution |
| MPF-PS 75 35-S | Length 35 mm | In distribution |
| MPF-BT 60 60-S | Length 60 mm | In distribution |
| MPF-ST 61 60-S | Length 160 mm | In distribution |
| MPF-ST 61 20-N | Length 120 mm | In distribution |
| MPF-PX 85 50-S | Outer Diameter 8.5 mm | In distribution |
| MPF-PS 85 30-S | Outer Diameter 8.5 mm | In distribution |
| MPF-BS 65 40-S | Length 40 mm | In distribution |
| MPF-BT 60 50-S | Length 50 mm | In distribution |
| MPF-ST 62 40-S | Length 240 mm | In distribution |
| MPF-IN 03 10-N | Angle 90 ° | In distribution |
| MPF-IN 26 00-N | In distribution | |
| MPF-BT 50 90-S | Length 90 mm | In distribution |
| MPF-BS 75 10-S | Outer Diameter 7.5 mm | In distribution |
| MPF-PS 75 60-S | Outer Diameter 7.5 mm | In distribution |
| MPF-ST 50 35-S | Length 35 mm | In distribution |
| MPF-ST 60 45-N | Length 45 mm | In distribution |
| MPF-PX 85 30-S | Outer Diameter 8.5 mm | In distribution |
| MPF-IN 31 00-N | In distribution | |
| MPF-ST 51 40-S | Length 140 mm | In distribution |
| MPF-PS 75 40-S | Outer Diameter 7.5 mm | In distribution |
| MPF-IN 04 00-N | In distribution | |
| MPF-PS 65 55-S | Length 55 mm | In distribution |
| MPF-IN 34 00-N | In distribution | |
| MPF-PS 85 90-S | Outer Diameter 8.5 mm | In distribution |
| MPF-ST 60 35-N | Length 35 mm | In distribution |
| MPF-PX 85 40-S | Outer Diameter 8.5 mm | In distribution |
| MPF-PS 65 40-S | Length 40 mm | In distribution |
| MPF-SX 55 60-S | Outer Diameter 5.5 mm | In distribution |
| MPF-ST 50 55-N | Length 55 mm | In distribution |
| MPF-ST 50 55-S | Length 55 mm | In distribution |
| MPF-PX 65 55-S | Outer Diameter 6.5 mm | In distribution |
| MPF-SS 45 40-S | Outer Diameter 4.5 mm | In distribution |
| MPF-SS 45 35-S | Outer Diameter 4.5 mm | In distribution |
| MPF-ST 62 00-S | Length 200 mm | In distribution |
| MPF-ST 51 50-S | Length 150 mm | In distribution |
| MPF-ST 51 20-N | Length 120 mm | In distribution |
| MPF-SX 85 35-N | Length 35 mm | In distribution |
| MPF-PX 45 30-S | Outer Diameter 4.5 mm | In distribution |
| MPF-SS 75 40-S | Outer Diameter 7.5 mm | In distribution |
| MPF-PS 15 11-S | Outer Diameter 10.5 mm | In distribution |
| MPF-IN 07 00-N | In distribution | |
| MPF-BS 75 80-S | Outer Diameter 7.5 mm | In distribution |
| MPF-ST 51 30-N | Length 130 mm | In distribution |
| MPF-SS 55 60-N | Length 60 mm | In distribution |
| MPF-BS 65 55-S | Length 55 mm | In distribution |
| MPF-SX 55 60-N | Length 60 mm | In distribution |
| MPF-SS 55 55-S | Outer Diameter 5.5 mm | In distribution |
| MPF-PS 95 90-S | Outer Diameter 9.5 mm | In distribution |
| MPF-SX 45 45-S | Outer Diameter 4.5 mm | In distribution |
| MPF-SX 45 45-N | Length 45 mm | In distribution |
| MPF-ST 51 50-N | Length 150 mm | In distribution |
| MPF-BT 51 20-S | Length 120 mm | In distribution |
| MPF-SS 55 30-N | Length 30 mm | In distribution |
| MPF-BT 51 10-S | Length 110 mm | In distribution |
| MPF-PX 75 35-S | Outer Diameter 7.5 mm | In distribution |
| MPF-SX 85 30-S | Outer Diameter 8.5 mm | In distribution |
| MPF-ST 61 00-N | Length 100 mm | In distribution |
| MPF-BT 60 90-S | Length 90 mm | In distribution |
| MPF-ST 50 40-N | Length 40 mm | In distribution |
| MPF-IN 33 00-N | In distribution | |
| MPF-ST 61 90-N | Length 190 mm | In distribution |
| MPF-IN 17 00-N | In distribution | |
| MPF-BT 50 50-S | Length 50 mm | In distribution |
| MPF-SS 45 40-N | Length 40 mm | In distribution |
| MPF-SX 75 35-N | Length 35 mm | In distribution |
| MPF-ST 62 40-N | Length 240 mm | In distribution |
| MPF-ST 62 50-S | Length 250 mm | In distribution |
| MPF-SS 55 25-N | Length 25 mm | In distribution |
| MPF-ST 61 10-S | Length 110 mm | In distribution |
| MPF-ST 50 60-N | Length 60 mm | In distribution |
| MPF-ST 60 40-N | Length 40 mm | In distribution |
| MPF-ST 62 30-S | Length 230 mm | In distribution |
| MPF-IN 29 00-N | In distribution | |
| MPF-ST 52 30-N | Length 230 mm | In distribution |
| MPF-SS 75 55-N | Length 55 mm | In distribution |
| MPF-PS 15 10-S | Outer Diameter 10.5 mm | In distribution |
| MPF-ST 60 80-S | Length 80 mm | In distribution |
| MPF-IN 16 70-N | Outer Diameter 7 mm | In distribution |
| MPF-SS 85 45-S | Outer Diameter 8.5 mm | In distribution |
| MPF-SX 55 30-N | Length 30 mm | In distribution |
| MPF-ST 50 60-S | Length 60 mm | In distribution |
| MPF-BS 75 12-S | Outer Diameter 7.5 mm | In distribution |
| MPF-PS 65 45-S | Length 45 mm | In distribution |
| MPF-SS 65 40-N | Length 40 mm | In distribution |
| MPF-SS 55 25-S | Outer Diameter 5.5 mm | In distribution |
| MPF-SX 75 45-S | Outer Diameter 7.5 mm | In distribution |
| MPF-PS 75 11-S | Outer Diameter 7.5 mm | In distribution |
| MPF-BS 55 55-S | Length 55 mm | In distribution |
| MPF-SS 65 45-N | Length 45 mm | In distribution |
| MPF-SS 45 35-N | Length 35 mm | In distribution |
| MPF-SX 75 30-N | Length 30 mm | In distribution |
| MPF-PX 55 60-S | Outer Diameter 5.5 mm | In distribution |
| MPF-BS 15 11-S | Outer Diameter 10.5 mm | In distribution |
| MPF-SX 55 25-N | Length 25 mm | In distribution |
| MPF-ST 50 30-N | Length 30 mm | In distribution |
| MPF-ST 52 40-S | Length 240 mm | In distribution |
| MPF-BS 85 80-S | Outer Diameter 8.5 mm | In distribution |
| MPF-BS 45 35-S | Length 35 mm | In distribution |
| MPF-SX 65 55-S | Outer Diameter 6.5 mm | In distribution |
| MPF-SS 75 45-N | Length 45 mm | In distribution |
| MPF-BT 50 85-S | Length 85 mm | In distribution |
| MPF-BS 55 45-S | Length 45 mm | In distribution |
| MPF-BS 85 45-S | Length 45 mm | In distribution |
| MPF-SX 85 30-N | Length 30 mm | In distribution |
| MPF-IN 08 00-N | In distribution | |
| MPF-BS 85 70-S | Outer Diameter 8.5 mm | In distribution |
| MPF-PS 55 45-S | Length 45 mm | In distribution |
| MPF-PX 65 40-S | Outer Diameter 6.5 mm | In distribution |
| MPF-SS 45 25-S | Outer Diameter 4.5 mm | In distribution |
| MPF-ST 61 50-N | Length 150 mm | In distribution |
| MPF-BT 60 55-S | Length 55 mm | In distribution |
| MPF-BX 01 00-N | In distribution | |
| MPF-ST 51 80-N | Length 180 mm | In distribution |
| MPF-SS 85 30-N | Length 30 mm | In distribution |
| MPF-BT 50 45-N | Length 45 mm | In distribution |
| MPF-SX 85 60-N | Length 60 mm | In distribution |
| MPF-SS 65 50-N | Length 50 mm | In distribution |
| MPF-SS 75 60-S | Outer Diameter 7.5 mm | In distribution |
| MPF-BS 75 90-S | Outer Diameter 7.5 mm | In distribution |
| MPF-SX 45 30-S | Outer Diameter 4.5 mm | In distribution |
| MPF-ST 50 50-S | Length 50 mm | In distribution |
| MPF-ST 60 60-N | Length 60 mm | In distribution |
| MPF-BS 95 80-S | Outer Diameter 9.5 mm | In distribution |
| MPF-PS 85 50-S | Outer Diameter 8.5 mm | In distribution |
| MPF-ST 52 10-S | Length 210 mm | In distribution |
| MPF-SX 65 30-N | Length 30 mm | In distribution |
| MPF-SX 65 25-S | Outer Diameter 6.5 mm | In distribution |
| MPF-BS 85 40-S | Length 40 mm | In distribution |
| MPF-PX 45 45-S | Outer Diameter 4.5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Spineart SA | UDI-DI | 2025-06-30 | Class II | Labeling Change Control | Cannulated fenestrated polyaxial screws may be incorrectly labeled | 16 units |
| Spineart SA | UDI-DI | 2025-06-30 | Class II | Labeling Change Control | Cannulated fenestrated polyaxial screws may be incorrectly labeled | 0 |
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.