Spira®-A Integrated

SPIRA®-A Integrated,Trial, 26x34mm, 25° Lordotic, 15mm

Registry build 21.09.26
53manufacturers in China registered for this device type
198catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for Spira®-A Integrated
Listed by Camber Spine Technologies, United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2024-12-16

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Spira®-A Integrated
Catalogue number Size Status
SPA-102-305 In distribution
SAZ-102-101 In distribution
SAZ-102-044 In distribution
SAZ-102-153 In distribution
SAZ-102-024 In distribution
SPA-116-107 In distribution
SAZ-102-122 In distribution
SAZ-102-053 In distribution
SAZ-102-013 In distribution
SAZ-102-081 In distribution
SAZ-135-003 In distribution
SAZ-116-001 In distribution
SAZ-102-123 In distribution
SAZ-102-147 In distribution
SAZ-102-084 In distribution
SAZ-102-154 In distribution
SAZ-102-090 In distribution
SAZ-102-118 In distribution
SAZ-102-006 In distribution
SAZ-102-102 In distribution
SAZ-102-150 In distribution
SAZ-102-031 In distribution
SAZ-102-022 In distribution
SAZ-102-056 In distribution
SAZ-103-211 In distribution
SAZ-102-088 In distribution
SAZ-102-035 In distribution
SAZ-102-048 In distribution
SAZ-102-034 In distribution
SAZ-102-037 In distribution
SAZ-102-064 In distribution
SAZ-102-143 In distribution
SAZ-102-001 In distribution
SAZ-102-111 In distribution
SAZ-102-028 In distribution
SAZ-103-101 In distribution
SAZ-102-110 In distribution
SAZ-102-052 In distribution
SAZ-102-057 In distribution
SAZ-102-103 In distribution
SAZ-102-117 In distribution
SAZ-102-050 In distribution
SAZ-102-097 In distribution
SAZ-102-083 In distribution
SAZ-102-060 In distribution
SPA-102-307 In distribution
SAZ-102-159 In distribution
SAZ-102-096 In distribution
SAZ-102-009 In distribution
SAZ-102-160 In distribution
SPA-116-109 In distribution
SAZ-102-073 In distribution
SAZ-102-099 In distribution
SAZ-102-139 In distribution
SAZ-103-219 In distribution
SAZ-105-016 In distribution
SAZ-102-152 In distribution
SPA-116-112 In distribution
SAZ-102-133 In distribution
SAZ-103-221 In distribution
SAZ-102-005 In distribution
SAZ-103-217 In distribution
SAZ-102-137 In distribution
SAZ-102-126 In distribution
SAZ-102-078 In distribution
SAZ-102-014 In distribution
SAZ-102-036 In distribution
SAZ-102-012 In distribution
SAZ-102-158 In distribution
SAZ-102-011 In distribution
SAZ-102-061 In distribution
SAZ-102-093 In distribution
SAZ-102-080 In distribution
SAZ-102-003 In distribution
SAZ-102-079 In distribution
SAZ-102-049 In distribution
SAZ-103-207 In distribution
SAZ-102-033 In distribution
SAZ-102-055 In distribution
SAZ-102-149 In distribution
SAZ-102-043 In distribution
SAZ-102-065 In distribution
SAZ-102-071 In distribution
SAZ-102-086 In distribution
SAZ-102-030 In distribution
SAZ-102-026 In distribution
SAZ-102-075 In distribution
SAZ-103-209 In distribution
SAZ-102-027 In distribution
SAZ-103-201 In distribution
SAZ-102-100 In distribution
SAZ-102-025 In distribution
SAZ-102-041 In distribution
SAZ-102-047 In distribution
SAZ-102-128 In distribution
SAZ-102-019 In distribution
SAZ-102-002 In distribution
SAZ-102-142 In distribution
SAZ-102-069 In distribution
SAZ-102-116 In distribution
SAZ-102-062 In distribution
SAZ-102-105 In distribution
SAZ-102-076 In distribution
SAZ-102-077 In distribution
SAZ-102-120 In distribution
SAZ-103-206 In distribution
SAZ-102-124 In distribution
SAZ-102-092 In distribution
SAZ-102-004 In distribution
SAZ-103-205 In distribution
SAZ-102-029 In distribution
SAZ-102-023 In distribution
SAZ-102-104 In distribution
SAZ-102-032 In distribution
SAZ-102-113 In distribution
SAZ-102-109 In distribution
SAZ-102-135 In distribution
SAZ-102-106 In distribution
SAZ-102-068 In distribution
SAZ-103-215 In distribution
SPA-116-119 In distribution
SAZ-102-140 In distribution
SAZ-102-070 In distribution
SAZ-102-157 In distribution
SAZ-102-063 In distribution
SAZ-102-132 In distribution
SAZ-102-008 In distribution
SAZ-102-130 In distribution
SAZ-102-054 In distribution
SAZ-500-106 In distribution
SAZ-102-155 In distribution
SAZ-102-112 In distribution
SAZ-102-046 In distribution
SPA-116-111 In distribution
SAZ-102-146 In distribution
SAZ-102-108 In distribution
SAZ-102-038 In distribution
SAZ-102-115 In distribution
SAZ-103-202 In distribution
SAZ-102-144 In distribution
SPA-116-108 In distribution
SAZ-102-125 In distribution
SAZ-102-094 In distribution
SAZ-102-082 In distribution
SAZ-102-138 In distribution
SAZ-102-016 In distribution
SAZ-102-131 In distribution
SAZ-102-089 In distribution
SAZ-102-045 In distribution
SAZ-102-134 In distribution
SPA-116-117 In distribution
SAZ-102-015 In distribution
SAZ-102-010 In distribution
SAZ-102-107 In distribution
SAZ-102-129 In distribution
SAZ-102-136 In distribution
SAZ-102-095 In distribution
SAZ-102-042 In distribution
CY-100-324 In distribution
SAZ-102-087 In distribution
SAZ-102-145 In distribution
SAZ-135-001 In distribution
SAZ-102-067 In distribution
SAZ-102-148 In distribution
SAZ-102-018 In distribution
SAZ-102-072 In distribution
SAZ-102-151 In distribution
SAZ-103-204 In distribution
SAZ-102-059 In distribution
SAZ-103-008 In distribution
SAZ-103-203 In distribution
SAZ-102-127 In distribution
SAZ-102-114 In distribution
SAZ-103-213 In distribution
SAZ-102-039 In distribution
SAZ-102-066 In distribution
SAZ-504-015 In distribution
SAZ-102-007 In distribution
SAZ-102-040 In distribution
SAZ-102-017 In distribution
SAZ-102-156 In distribution
SAZ-102-091 In distribution
SPA-116-113 In distribution
SPA-116-115 In distribution
SPA-116-110 In distribution
SAZ-102-020 In distribution
SAZ-102-021 In distribution
SAZ-117-106 In distribution
SAZ-102-058 In distribution
SAZ-102-141 In distribution
SAZ-117-412 In distribution
SPA-116-001 In distribution
SAZ-102-074 In distribution
SAZ-102-119 In distribution
SAZ-102-051 In distribution
SAZ-102-085 In distribution
SAZ-102-098 In distribution
SAZ-102-121 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument

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