Perla ®
KIT OF 2 ADJUSTABLE OCCIPITAL RODS TITANIUM Size M
4manufacturers in China registered for this device type
349catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-02-08 |
| Record revised | 2025-03-31 (version 7) |
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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Pack of 2 |
| Sizes | Length 3.5 to 600 mm; outer diameter 3.2 to 52 mm; angle 90 to 130 °; height 32 to 36 mm |
| Distribution end date | 2021-03-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPF-SS 04 20-S | Length 20 mm | In distribution |
| CPF-OR TM 13-S | Angle 130 ° | In distribution |
| CPF-CS 35 12-S | Length 12 mm | In distribution |
| CPF-OR TS 13-S | Angle 130 ° | In distribution |
| CPF-PR T0 60-S | Length 60 mm | In distribution |
| CPF-MS 04 44-S | Length 44 mm | In distribution |
| CPF-SS 04 26-S | Length 26 mm | In distribution |
| CPF-PS 45 48-S | Length 48 mm | In distribution |
| CPF-SR T0 25-S | Length 25 mm | In distribution |
| CPF-HO ST 0S-S | In distribution | |
| CPF-MS 35 08-S | Length 08 mm | In distribution |
| CPF-PS 04 20-S | Length 20 mm | In distribution |
| CPF-T5 C3 00-S | Outer Diameter 5.5 mm | In distribution |
| CPF-MS 35 14-S | Length 14 mm | In distribution |
| CPF-IN 62 00-N | In distribution | |
| CPF-OS 05 06-S | Outer Diameter 5 mm | In distribution |
| CPF-IN 52 20-N | Outer Diameter 4.2 mm | In distribution |
| CPF-OR CM 11-S | Angle 110 ° | In distribution |
| CPF-CH 20 25-S | In distribution | |
| CPF-CR 23 26-S | In distribution | |
| CPF-SR C0 70-S | Length 70 mm | In distribution |
| CPF-MS 35 44-S | Length 44 mm | In distribution |
| CPF-SR C0 45-S | Length 45 mm | In distribution |
| CPF-IN 55 00-N | In distribution | |
| CPF-SR T1 20-S | Length 120 mm | In distribution |
| CPF-CS 04 18-S | Length 18 mm | In distribution |
| CPF-PS 45 24-S | Length 24 mm | In distribution |
| CPF-SS 35 34-S | Length 34 mm | In distribution |
| CPF-SR C0 90-S | Length 90 mm | In distribution |
| CPF-PR T0 55-S | Length 55 mm | In distribution |
| CPF-CS 35 16-S | Length 16 mm | In distribution |
| CPF-SR C0 40-S | Length 40 mm | In distribution |
| CPF-SR T0 45-S | Length 45 mm | In distribution |
| CPF-CS 04 08-S | Length 08 mm | In distribution |
| CPF-SR T0 70-S | Length 70 mm | In distribution |
| CPF-HO OF LL-S | In distribution | |
| CPF-IN 51 00-N | Outer Diameter 3.2 mm | In distribution |
| CPF-SR C0 85-S | Length 85 mm | In distribution |
| CPF-T6 C6 00-S | Outer Diameter 6 mm | In distribution |
| CPF-IN 52 00-N | Outer Diameter 3.7 mm | In distribution |
| CPF-OR TM AD-S | In distribution | |
| CPF-IN 56 20-N | In distribution | |
| CPF-CS 04 32-S | Length 32 mm | In distribution |
| CPF-PS 45 40-S | Length 40 mm | In distribution |
| CPF-SR T0 55-S | Length 55 mm | In distribution |
| CPF-PC 3C 6O-S | In distribution | |
| CPF-PS 04 48-S | Length 48 mm | In distribution |
| CPF-TR C3 00-S | Length 300 mm | In distribution |
| CPF-PS 35 18-S | Length 18 mm | In distribution |
| CPF-PS 35 24-S | Length 24 mm | In distribution |
| CPF-IN 54 10-N | In distribution | |
| CPF-PS 04 16-S | Length 16 mm | In distribution |
| CPF-CS 35 44-S | Length 44 mm | In distribution |
| CPF-PS 35 52-S | Length 52 mm | In distribution |
| CPF-MS 04 18-S | Length 18 mm | In distribution |
| CPF-SS 35 18-S | Outer Diameter 3.5 mm | In distribution |
| CPF-OR TS AR-S | In distribution | |
| CPF-PC 3O 6C-S | In distribution | |
| CPF-PS 04 12-S | Length 12 mm | In distribution |
| CPF-IN 56 30-N | In distribution | |
| CPF-MS 04 20-S | Length 20 mm | In distribution |
| CPF-CS 04 16-S | Length 16 mm | In distribution |
| CPF-PS 04 14-S | Length 14 mm | In distribution |
| CPF-CR 32 44-S | In distribution | |
| CPF-PC 3C 5O-S | In distribution | |
| CPF-AC 3C 5O-S | In distribution | |
| CPF-SS 35 32-S | Length 32 mm | In distribution |
| CPF-IN 07 08-S | Length 08 mm | In distribution |
| CPF-SR T0 50-S | Length 50 mm | In distribution |
| CPF-SR T0 20-S | Length 20 mm | In distribution |
| CPF-LC 00 0S-S | In distribution | |
| CPF-IN 07 12-S | Length 12 mm | In distribution |
| CPF-SR T0 90-S | Length 90 mm | In distribution |
| CPF-IN 07 14-S | Length 14 mm | In distribution |
| CPF-HO OF SL-S | In distribution | |
| CPF-OS 05 10-S | Outer Diameter 5 mm | In distribution |
| CPF-IN 53 00-N | Length 6 mm | In distribution |
| CPF-SR T0 40-S | Length 40 mm | In distribution |
| CPF-SR T0 35-S | Length 35 mm | In distribution |
| CPF-SS 35 30-S | Length 30 mm | In distribution |
| CPF-PS 35 20-S | Length 20 mm | In distribution |
| CPF-CS 35 14-S | Length 14 mm | In distribution |
| CPF-SR C0 65-S | Length 65 mm | In distribution |
| CPF-PR T0 85-S | Length 85 mm | In distribution |
| CPF-OS 05 08-S | Outer Diameter 5 mm | In distribution |
| CPF-MS 35 20-S | Outer Diameter 3.5 mm | In distribution |
| CPF-PR C0 65-S | Length 65 mm | In distribution |
| CPF-CS 35 28-S | Length 28 mm | In distribution |
| CPF-IN 53 10-N | Length 10 mm | In distribution |
| CPF-MS 04 32-S | Length 32 mm | In distribution |
| CPF-IN 63 00 -N | In distribution | |
| CPF-OR TS 11-S | Angle 110 ° | In distribution |
| CPF-CR 26 32-S | In distribution | |
| CPF-PS 35 16-S | Length 16 mm | In distribution |
| CPF-PS 45 14-S | Length 14 mm | In distribution |
| CPF-CS 04 10-S | Length 10 mm | In distribution |
| CPF-PS 04 08-S | Length 08 mm | In distribution |
| CPF-SR C2 40-S | Length 240 mm | In distribution |
| CPF-PS 04 44-S | Length 44 mm | In distribution |
| CPF-CH 45 50-S | In distribution | |
| CPF-OR TS AD-S | In distribution | |
| CPF-IN 52 10-N | Outer Diameter 4.2 mm | In distribution |
| CPF-SR T0 75-S | Length 75 mm | In distribution |
| CPF-TR T6 00-S | Length 600 mm | In distribution |
| CPF-CS 35 52-S | Length 52 mm | In distribution |
| CPF-PS 35 48-S | Length 48 mm | In distribution |
| CPF-SR T0 65-S | Length 65 mm | In distribution |
| CPF-SR T0 60-S | Length 60 mm | In distribution |
| SPE-US 00 28-N | In distribution | |
| CPF-PS 04 36-S | Length 36 mm | In distribution |
| CPF-PS 35 44-S | Length 44 mm | In distribution |
| CPF-SR T1 00-S | Length 100 mm | In distribution |
| CPF-OR TM 90-S | Angle 90 ° | In distribution |
| CPF-PR C0 40-S | Length 40 mm | In distribution |
| CPF-CS 04 40-S | Length 40 mm | In distribution |
| CPF-PS 45 10-S | Length 10 mm | In distribution |
| CPF-SR T3 50-S | Length 350 mm | In distribution |
| CPF-PR T0 75-S | Length 75 mm | In distribution |
| CPF-PR T0 70-S | Length 70 mm | In distribution |
| CPF-PC CO TC-S | In distribution | |
| CPF-MS 04 12-S | Length 12 mm | In distribution |
| CPF-SS 04 34-S | Length 34 mm | In distribution |
| CPF-SS 35 22-S | Length 22 mm | In distribution |
| CPF-MS 35 18-S | Length 18 mm | In distribution |
| CPF-PR T0 90-S | Length 90 mm | In distribution |
| CPF-SS 04 22-S | Length 22 mm | In distribution |
| CPF-PR T0 80-S | Length 80 mm | In distribution |
| CPF-CR 21 23-S | In distribution | |
| CPF-T6 C3 00-S | Outer Diameter 6 mm | In distribution |
| CPF-T5 C6 00-S | Outer Diameter 5.5 mm | In distribution |
| CPF-CS 35 08-S | Length 08 mm | In distribution |
| CPF-SR C0 30-S | Length 30 mm | In distribution |
| CPF-SR C0 25-S | Length 25 mm | In distribution |
| CPF-IN 51 10-N | Outer Diameter 3.2 mm | In distribution |
| CPF-MS 04 10-S | Length 10 mm | In distribution |
| CPF-HO OF SR-S | In distribution | |
| CPF-PS 35 28-S | Length 28 mm | In distribution |
| CPF-SR C0 35-S | Length 35 mm | In distribution |
| CPF-CH 35 40-S | In distribution | |
| CPF-CS 35 20-S | Length 20 mm | In distribution |
| CPF-SS 35 28-S | Length 28 mm | In distribution |
| CPF-OS 45 14-S | Outer Diameter 4.5 mm | In distribution |
| CPF-T5 T6 00-S | Outer Diameter 5.5 mm | In distribution |
| CPF-OS 45 12-S | Outer Diameter 4.5 mm | In distribution |
| CPF-IN 08 00-S | In distribution | |
| CPF-MS 04 16-S | Length 16 mm | In distribution |
| CPF-PR C0 75-S | Length 75 mm | In distribution |
| CPF-SR C0 20-S | Length 20 mm | In distribution |
| CPF-SR T0 30-S | Length 30 mm | In distribution |
| CPF-OR CS 11-S | Angle 110 ° | In distribution |
| CPF-CS 35 48-S | Length 48 mm | In distribution |
| CPF-PS 35 32-S | Length 32 mm | In distribution |
| CPF-IN 56 40-N | In distribution | |
| CPF-PR C0 50-S | Length 50 mm | In distribution |
| CPF-SR C1 10-S | Outer Diameter 3.5 mm | In distribution |
| CPF-MS 35 36-S | Length 36 mm | In distribution |
| CPF-SR C3 50-S | Length 350 mm | In distribution |
| CPF-CS 04 28-S | Length 28 mm | In distribution |
| CPF-OR TM AL-S | In distribution | |
| CPF-MS 04 14-S | Length 14 mm | In distribution |
| CPF-PS 04 52-S | Length 52 mm | In distribution |
| CPF-OR TS AL-S | In distribution | |
| CPF-IN 56 00-N | In distribution | |
| CPF-IN 07 10-S | Length 10 mm | In distribution |
| CPF-PR C0 80-S | Length 80 mm | In distribution |
| CPF-MS 04 48-S | Length 48 mm | In distribution |
| CPF-PR C0 55-S | Length 55 mm | In distribution |
| CPF-IN 07 18-S | Length 18 mm | In distribution |
| CPF-OP 00 0L-S | In distribution | |
| CPF-IN 54 30-N | In distribution | |
| CPF-IN 07 16-S | Length 16 mm | In distribution |
| CPF-T6 T3 00-S | Outer Diameter 6 mm | In distribution |
| CPF-CS 04 24-S | Length 24 mm | In distribution |
| CPF-SR T2 40-S | Length 240 mm | In distribution |
| CPF-PS 04 32-S | Height 32 mm | In distribution |
| CPF-CH 30 35-S | In distribution | |
| CPF-SR C0 55-S | Length 55 mm | In distribution |
| CPF-OS 05 14-S | Outer Diameter 5 mm | In distribution |
| CPF-PS 35 08-S | Length 08 mm | In distribution |
| CPF-PR C0 45-S | Length 45 mm | In distribution |
| CPF-IN 51 00-S | Outer Diameter 3.2 mm | In distribution |
| CPF-CH 40 45-S | In distribution | |
| CPF-SC 01 00-S | In distribution | |
| CPF-SS 04 32-S | Length 32 mm | In distribution |
| CPF-SR C0 50-S | Length 50 mm | In distribution |
| CPF-CS 35 18-S | Length 18 mm | In distribution |
| CPF-SS 04 30-S | Length 30 mm | In distribution |
| CPF-PR T0 40-S | Length 40 mm | In distribution |
| CPF-CH 25 30-S | In distribution | |
| CPF-PC 3C 3C-S | In distribution | |
| CPF-IN 07 50-S | Length 560 mm | In distribution |
| CPF-CS 04 48-S | Length 48 mm | In distribution |
| CPF-CS 04 44-S | Length 44 mm | In distribution |
| CPF-CS 04 20-S | Length 20 mm | In distribution |
| CPF-IN 54 00-N | In distribution | |
| CPF-MS 04 24-S | Length 24 mm | In distribution |
| CPF-SS 35 20-S | Length 20 mm | In distribution |
| CPF-PR T0 45-S | Length 45 mm | In distribution |
| CPF-BX 20 00-N | In distribution | |
| CPF-SR T0 85-S | Length 85 mm | In distribution |
| CPF-SS 04 24-S | Length 24 mm | In distribution |
| CPF-IN 54 20-N | In distribution | |
| CPF-MS 35 24-S | Length 24 mm | In distribution |
| CPF-MS 35 10-S | Length 10 mm | In distribution |
| CPF-PR C0 60-S | Length 60 mm | In distribution |
| CPF-PR T0 50-S | Length 50 mm | In distribution |
| CPF-T5 T3 00-S | Outer Diameter 5.5 mm | In distribution |
| CPF-MS 35 28-S | Length 28 mm | In distribution |
| CPF-OR TM AR-S | In distribution | |
| CPF-SC 00 00-S | In distribution | |
| CPF-PR C0 85-S | Length 85 mm | In distribution |
| CPF-PS 04 18-S | Length 18 mm | In distribution |
| CPF-OS 45 08-S | Outer Diameter 4.5 mm | In distribution |
| CPF-PC 3O 3C-S | In distribution | |
| CPF-SR C0 80-S | Length 80 mm | In distribution |
| CPF-HO OF LR-S | In distribution | |
| CPF-CS 35 10-S | Length 10 mm | In distribution |
| CPF-OP 00 0S-S | In distribution | |
| CPF-PS 35 12-S | Length 12 mm | In distribution |
| CPF-CS 04 12-S | Length 12 mm | In distribution |
| CPF-PS 35 36-S | Length 36 mm | In distribution |
| CPF-OS 05 16-S | Outer Diameter 5 mm | In distribution |
| CPF-OS 45 10-S | Outer Diameter 4.5 mm | In distribution |
| CPF-OR TM 11-S | Angle 110 ° | In distribution |
| CPF-OR CM 13-S | Angle 130 ° | In distribution |
| CPF-PS 04 10-S | Length 10 mm | In distribution |
| CPF-MS 35 16-S | Length 16 mm | In distribution |
| CPF-LC 00 0L-S | In distribution | |
| CPF-PS 35 40-S | Length 40 mm | In distribution |
| CPF-PR C0 90-S | Length 90 mm | In distribution |
| CPF-OR CS 13-S | Angle 130 ° | In distribution |
| CPF-TR T3 00-S | Length 300 mm | In distribution |
| CPF-SR C0 75-S | Length 75 mm | In distribution |
| CPF-IN 50 10-N | In distribution | |
| CPF-PS 04 28-S | Length 28 mm | In distribution |
| CPF-SR T1 10-S | Length 110 mm | In distribution |
| CPF-IN 53 20-N | Length 14 mm | In distribution |
| CPF-CS 35 36-S | Length 36 mm | In distribution |
| CPF-AC 3O 5C-S | In distribution | |
| CPF-MS 04 28-S | Length 28 mm | In distribution |
| CPF-MS 04 36-S | Length 36 mm | In distribution |
| CPF-IN 55 10-N | In distribution | |
| CPF-SS 04 28-S | Length 28 mm | In distribution |
| CPF-OR TS 90-S | Angle 90 ° | In distribution |
| CPF-PC CC TO-S | In distribution | |
| CPF-T6 T6 00-S | Outer Diameter 6 mm | In distribution |
| CPF-SC 02 00-S | In distribution | |
| CPF-PS 45 18-S | Length 18 mm | In distribution |
| CPF-SC 00 02-S | In distribution | |
| CPF-CS 35 40-S | Length 40 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200571 | 2020-05-01 |
| K190071 | 2019-02-25 |
| K153386 | 2016-01-25 |
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.