FDA.reportPublic FDA data

Overwatch PCF

Primary DI
00840606195799
Brand
Overwatch PCF
Company
SPINAL ELEMENTS, INC.
Model
33043-002
Device description
TAP, DL Ø4.5 MM
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606195799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606195799008406061957998406061957990840606195799

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7606070121customerservice@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606168533SAPPHIRE X27002-0352026-08-27
00840606168557SAPPHIRE X27002-0372026-08-27
00840606168571SAPPHIRE X27002-0392026-08-27
00840606168588SAPPHIRE X27002-0402026-08-27
00840606168595SAPPHIRE X27002-0412026-08-27
00840606168601SAPPHIRE X27002-0422026-08-27
00840606168618SAPPHIRE X27002-0432026-08-27
00840606168625SAPPHIRE X27002-0442026-08-27
00840606168632SAPPHIRE X27002-0452026-08-27
00840606168656SAPPHIRE X27003-0372026-08-27
00840606168663SAPPHIRE X27003-0382026-08-27
00840606168687SAPPHIRE X27003-0402026-08-27
00840606168694SAPPHIRE X27003-0412026-08-27
00840606168717SAPPHIRE X27003-0432026-08-27
00840606168748SAPPHIRE X27003-0462026-08-27
00840606168755SAPPHIRE X27003-0472026-08-27
00840606168779SAPPHIRE X27003-0492026-08-27
00840606168786SAPPHIRE X27003-0502026-08-27
00840606168809SAPPHIRE X27003-0522026-08-27
00840606168816SAPPHIRE X27003-0532026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
00840606191883Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191890Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191906Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195782Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195805Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195812Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
07290019361343OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361350OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361367OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361374OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361381OSSIO® TapOSSIO LTDHWX2026-07-19
18257200076581CETRAOrthofix US LLCHWX2026-07-17
18257200076604CETRAOrthofix US LLCHWX2026-07-17
18257200076611CETRAOrthofix US LLCHWX2026-07-17
18257200076628CETRAOrthofix US LLCHWX2026-07-17
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22