B-Bop

FDA UDI

Class II (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: B-BOP FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a greater degree of correction. Due to the leverage effect, the osteotomy site is subject to significant dorsiflexion stress. The B-BOP plate is specifically designed for basal osteotomy of the first metatarsal, with strong stability. The set includes the B-BOP plates, screws, and instruments, including K-wire. FDA UDI
Model / Reference: BBOPSET FDA UDI
Description: In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a greater degree of correction. Due to the leverage effect, the osteotomy site is subject to significant dorsiflexion stress. The B-BOP plate is specifically designed for basal osteotomy of the first metatarsal, with strong stability. The set includes the B-BOP plates, screws, and instruments, including K-wire. FDA UDI

Identifiers

Catalog Number: BBOPSET FDA UDI
Primary DI / UDI-DI: 10381780064381 FDA UDI
FDA Product Code: HRS FDA UDI
HTY FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

B-Bop by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Newdeal Sas

Sources (1)

FDA UDI 1f6825dd-f4bf-4ae5-a07e-3a8972b59baa 37 fields · synced Jun 8, 2026