Overwatch

40 IN-LB Torque Handle, 3/16 SQ Internal Adaptor Cannulated

Registry build 21.09.26
53manufacturers in China registered for this device type
251catalogue 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 Overwatch
Listed by Spinal Elements, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-10-16
Record revised 2023-05-03 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2024-10-14
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Overwatch
Catalogue number Size Status
K0950 In distribution
108-320-118 In distribution
AISB-0019AR In distribution
108-314-040 In distribution
108-319-120 In distribution
108-112 In distribution
SP-0557-C55 In distribution
108-331 In distribution
T20-00-07-0 In distribution
ABP-803060HC In distribution
T20-00-06-0 In distribution
108-315-075 In distribution
108-106-03 In distribution
APA-706044HC In distribution
108-319-312 In distribution
108-320-124 In distribution
108-305 In distribution
108-320-126 In distribution
SE-2TMD3 In distribution
108-504 In distribution
108-320-418 In distribution
SP-0568 In distribution
ABP-303075A In distribution
ATD-910010-40-A In distribution
108-319-409 In distribution
108-110 In distribution
108-404-95 In distribution
SP-1RP9-C09 In distribution
T20-00-12-C In distribution
108-104-65 In distribution
T20-00-11-0 In distribution
108-226-1 In distribution
108-320-226 In distribution
108-317 In distribution
SP-0557-S55 In distribution
ARI-204003HC In distribution
108-310 In distribution
108-104-75 In distribution
SP-0564-2F In distribution
108-320-120 In distribution
108-315-085 In distribution
SP-0564-3 In distribution
SP-0555 In distribution
108-102 In distribution
108-104-C45 In distribution
108-326-05 In distribution
108-104-85 In distribution
108-104-C85 In distribution
108-114 In distribution
108-205 In distribution
SP-0564-2 In distribution
SP-1RP9-C01 In distribution
108-319-420 In distribution
APA-606078A In distribution
SP-0551 In distribution
ARI-701004A In distribution
108-319-220 In distribution
SP-0569 In distribution
AG900024B In distribution
108-319-112 In distribution
108-106-02 In distribution
K1150 In distribution
T20-00-09-0 In distribution
ABP-803059A In distribution
ASP-501012 In distribution
108-320-320 In distribution
108-225 In distribution
T20-00-08-C In distribution
T20-02-11-0 In distribution
1AD15 In distribution
T20-00-08-0 In distribution
108-318 In distribution
AISB-0019HC In distribution
108-104-45 In distribution
T20-00-05-0 In distribution
K0850 In distribution
108-329 In distribution
108-320-420 In distribution
108-407-01-S In distribution
SP-0557-S75 In distribution
108-501N In distribution
ANR-701528HC In distribution
K1050 In distribution
SP-0543 In distribution
1RT29-C01 In distribution
108-321 In distribution
SP-108-2006 In distribution
AISB-0019HCL In distribution
AISB-0019HCR In distribution
T20-02-12-0 In distribution
108-320-426 In distribution
108-319-224 In distribution
T20-00-06-C In distribution
ABP-303075HC In distribution
108-407-01-C In distribution
ATD-910010-40-HC In distribution
T20-00-07-C In distribution
108-104-40 In distribution
ANR-701528A In distribution
SP-0508 In distribution
108-320-318 In distribution
SP-0564-2M In distribution
108-326-02 In distribution
108-404-75 In distribution
ARG-000033 In distribution
AISB-0019A In distribution
108-326-01 In distribution
108-228 In distribution
A2RT13-C01 In distribution
ARG-000614A In distribution
108-404-105 In distribution
AgS83.7228 In distribution
108-227 In distribution
108-319-424 In distribution
108-326 In distribution
SP-0557-C65 In distribution
108-315-055 In distribution
ABP-803060A In distribution
108-107-02-L1 In distribution
108-312 In distribution
108-315-095 In distribution
SP-0593 In distribution
A2RT14-C01 In distribution
T20-02-08-0 In distribution
SP-0594 In distribution
11000-13M In distribution
108-226-2 In distribution
108-250 In distribution
108-320-128 In distribution
108-314-045 In distribution
108-320-224 In distribution
ARG-0000614HC In distribution
108-505 In distribution
T20-00-12-0 In distribution
A1FT43-C01 In distribution
SP-0557-S45 In distribution
SP-0547-S In distribution
108-330 In distribution
108-319-418 In distribution
108-311 In distribution
SP-0580 In distribution
ARI-701004HC In distribution
108-319-412 In distribution
108-107-07 In distribution
108-506 In distribution
108-320-324 In distribution
93-66 In distribution
108-107-02-S2 In distribution
108-107-01-S In distribution
NR-401065XX In distribution
108-503W In distribution
108-320-328 In distribution
108-319-318 In distribution
108-319-320 In distribution
108-320-228 In distribution
2TMD3 In distribution
SP-0596 In distribution
108-306 In distribution
108-404-85 In distribution
SP-0564-3M In distribution
108-320-424 In distribution
SP-0557-C45 In distribution
ATD-905079-80-A In distribution
T20-02-06-0 In distribution
T20-00-10-C In distribution
108-111-2 In distribution
ACB-000004HCR In distribution
ARTS-550300ACW In distribution
108-104-55 In distribution
SP-0566-65 In distribution
T20-02-05-0 In distribution
108-120 In distribution
108-320-428 In distribution
108-211 In distribution
108-319-209 In distribution
ACB-000004HCL In distribution
108-104-C65 In distribution
108-105 In distribution
SP-0511 In distribution
108-315-065 In distribution
108-319-212 In distribution
108-501W In distribution
108-107-05 In distribution
108-107-02-S1 In distribution
108-319-124 In distribution
APA-606078HC In distribution
SP-0547-C In distribution
ARB-000025HC In distribution
SP-0507-S1 In distribution
62294-000 In distribution
108-113 In distribution
62293-000 In distribution
ACB-000004HC In distribution
SP-0557-C75 In distribution
108-104-95 In distribution
ARG-000614HC In distribution
ARI-204004A In distribution
ATD-905063-80-A In distribution
108-503N In distribution
T20-00-09-C In distribution
108-319-109 In distribution
SP-0557-S65 In distribution
108-319-324 In distribution
108-106-01 In distribution
SP-0507-S2 In distribution
108-111-3 In distribution
108-103 In distribution
T20-00-11-C In distribution
SP-2AD2 In distribution
108-319-118 In distribution
108-262-00 In distribution
1FC6-C01 In distribution
108-319-309 In distribution
108-230 In distribution
SP-0517 In distribution
AISB-0019AL In distribution
108-322 In distribution
108-502W In distribution
108-107-02-L2 In distribution
T20-02-07-0 In distribution
ASP-501013 In distribution
ABP-803059HC In distribution
108-235 In distribution
ATD-905063-80-HC In distribution
108-201 In distribution
108-300 In distribution
SP-1RP9-C04 In distribution
T20-00-05-C In distribution
108-320-220 In distribution
108-260-00 In distribution
108-320-218 In distribution
108-111-1 In distribution
SP-0564 In distribution
108-104-C55 In distribution
108-324 In distribution
108-502N In distribution
108-229 In distribution
108-157-02 In distribution
SP-0566-55 In distribution
108-111-4 In distribution
108-319-218 In distribution
108-320-326 In distribution
SP-108-260-00 In distribution
APA-706044A In distribution
108-104-C75 In distribution
ATLR-605010-80-A In distribution
SP-0564-2FM In distribution
T20-02-09-0 In distribution
SP-0564-1 Withdrawn
ARB-000019A Withdrawn

Showing 250 of 251 catalogue numbers.

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