SeaSpine Spacer System – Pacifica

Paddle Scraper, Long, Convex, 15mm

Registry build 21.09.26
12manufacturers in China registered for this device type
37catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Guangdong (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTR
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25

Record

Regulatory record for SeaSpine Spacer System – Pacifica
Listed by Seaspine Orthopedics Corporation, United States
FDA product code HTR
Device type Rasp
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-03-31
Record revised 2026-02-24 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for SeaSpine Spacer System – Pacifica
Catalogue number Size Status
93-3606 13mm In distribution
93-3482 12mm In distribution
93-3480 10mm In distribution
93-3602 9mm In distribution
93-3698 15mm In distribution
93-3608 15mm In distribution
93-3154 In distribution
93-3484 14mm In distribution
93-3479 9mm In distribution
93-3601 8mm In distribution
93-3695 12mm In distribution
93-3600 7mm In distribution
93-3477 7mm In distribution
93-3701 18mm In distribution
93-3611 18mm In distribution
93-3610 17mm In distribution
93-3696 13mm In distribution
93-3605 12mm In distribution
93-3487 17mm In distribution
93-3691 8mm In distribution
93-3486 16mm In distribution
93-3609 16mm In distribution
93-3693 10mm In distribution
93-3488 18mm In distribution
93-3478 8mm In distribution
93-3697 14mm In distribution
93-3603 10mm In distribution
93-3690 7mm In distribution
93-3700 17mm In distribution
93-3699 16mm In distribution
93-3694 11mm In distribution
93-3607 14mm In distribution
93-3485 15mm In distribution
93-3604 11mm In distribution
93-3483 13mm In distribution
93-3481 11mm In distribution
93-3692 9mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 240
TiWAVE C Cervical Cage System Kalitec Direct, LLC 232
Tranquil-C™ Nexus Spine, L.L.C. 158
Calix Spinal Implant System Xtant Medical Holdings, Inc. 143
Rasp Medtronic Sofamor Danek, Inc. 109
Specials Seaspine Orthopedics Corporation 109
Stryker Avalign Technologies, Inc. 105
Endoskeleton® TAS Medtronic Sofamor Danek, Inc. 93
Intervertebral Disc Preparation Instruments Alphatec Spine, Inc. 90
Cambria Seaspine Orthopedics Corporation 85
IdentiTi Alphatec Spine, Inc. 83
Link Instruments – Rasps, compressors and broaches Waldemar Link GmbH & Co. KG 83

Showing 12 of 378. All products under Rasp

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer