FDA.report

Tecomet

Primary DI
00841435111509
Company
TECOMET INC.
Model
48274
Device description
BOW X-LARGE
Published
2026-03-02
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

Related Records

Regulatory Flags

DUNS number
078749695
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00841435111509PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00841435111509PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
LXHOrthopedic Manual Surgical Instrument1Orthopedic888.4540NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Bone approximation clampA hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
262-925-4531julie.davis@tecomet.com

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00841435111158Tecomet482462025-08-27
00841435111165Tecomet482542025-08-27
00841435111172Tecomet482482025-08-27
00841435111189Tecomet482592025-08-27
00841435111202Tecomet482692025-08-27
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00841435118287Tecomet004819014002025-08-27
00841435118317TecometK000-20102025-08-27
00841435111196Tecomet482622023-07-13

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